Job Description

Our Digital Manufacturing Operations Team supporting our vibrant West Point site is seeking a Process Automation Engineer Specialist to join their Team. This role will provide automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe.

Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations.

General responsibilities include:

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.
• Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities
• Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.
• Build relationships with functional counterparts and stakeholders in the business to proactively. identify and resolve technical issues.
• Lead or participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
• Stay current with latest automation technologies and trends and make recommendations for adoption
• Provide off-site weekend/evening automation phone or on-site support for our 24/7 manufacturing operations.

Skill Requirements:

• Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment

Preferred Skills:

• Experience in GMP Manufacturing - pharmaceutical/ biotechnology industry.
• Familiarly with Computer system validation and regulatory GXP requirements.
• Aseptic processing/sterile manufacturing experience.
• Technical and operational expertise in the DeltaV DCS, Allen-Bradley PLC, SCADA, HMI ASi/Field/Profibus or other related technologies.
• Networking, Virtual Machines, Database management and other general IT administration.
• Experience with data analytics tools (e.g. Spotfire, PowerBI)

Education Requirements:

• BS in Engineering, Computer Science or related field with 2 years of experience (GMP Manufacturing and/or Manufacturing Automation)
• Or
• High School Diploma and with 4 years of experience (GMP Manufacturing and/or Manufacturing Automation)

MSJR

VETJOBS

Required Skills:

Data Management, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Processes, Process Control, Process Manufacturing, Real-Time Programming, Regulatory Requirements, Software Development Life Cycle (SDLC), TIBCO Spotfire

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/1/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. We are seeking a passionate and experienced Associate Director of Engineering to join our team. This role offers a unique opportunity to contribute to the development of cutting-edge biologic and vaccine drug substances, drug products, and medical device combination products. If you are driven by the power of leading-edge science and want to make a meaningful impact on global health, we invite you to apply.

Responsibilities:

• Provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs).
• Influence oral solid dosage form packaging design as needed based on complexity.
• Understand considerations of complex packaging design and the interplay between product and package.
• Identify and mitigate risks through structural and materials design optimization.
• Collaborate with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products.
• Upskill fellow packaging engineers on risk-based experimental design and data analysis.
• Build inclusive, collaborative partnerships with internal and external stakeholders.
• Display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms.
• Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.
• Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs.

Education Requirements:

• Bachelors degree (B.S./B.A) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR
• Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience; OR
• PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience.

Required Experience and Skills:

• Large molecule autoinjector design experience
• End-to-End experience in packaging of pharmaceutical and/or medical device/combination products.
• Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
• Experience with a variety of primary, secondary, and tertiary packaging types common in the biopharmaceutical industry.
• Use of design and modeling tools to enhance understanding of distribution stresses and packaging dynamics.
• Ability to determine interrogate the science, identify true requirements, and proactively detect critical flaws.
• Leadership skills to enable collaboration with diverse business partners.
• Ability to drive complex projects to completion in a fast-paced environment.
• Ability to navigate ambiguity, embrace experimentation and learning, and model a growth mindset.
• Ability to identify technical capability gaps and influence other engineers.
• Excellent technical written and oral communication skills.
• Proficient in problem solving, risk-based decision-making, and use of standard work.
• Ability to maintain subject matter expertise and help the organization grow and learn in packaging development.

Preferred Experience and Skills:

• Background in application of numerical design and modeling tools.
• Quality by Design (QbD) experience.
• Experience in defining standard work processes and documents.
• Experience specifying, processing, and characterizing packaging materials.
• Expertise in hypothesis development and testing, statistical analysis, and Design of Experiments.
• Lean Six Sigma or Design for Six Sigma certification.

This document contains AI-generated content.

Required Skills:

Biologics, Combination Products, Compliance Packaging, Engineering Standards, Good Manufacturing Practices (GMP), Injection Devices, Leadership, Manufacturing Scale-Up, Packaging Engineering, Process Optimization, Root Cause Analysis (RCA), Technical Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Applications are sought for a senior specialist position in our Research & Development Division's Biologics Pilot Plant (BPP) automation engineering group.  Individual will lead and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

Candidate will participate in a range of activities including, but are not limited to:

• Technically lead ongoing automation system support in the facility
• Provide automation expertise for GMP clinical manufacturing campaigns in the facility
• Lead and/or execute the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements
• Author and review GMP change controls, test protocols, SDLC documentation, SOP’s, safety reviews, deviation investigations and actions
• Lead ongoing maintenance and upgrade projects for automation systems in the facility
• Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiency
• Cross train in many areas and technologies
• Actively work in a multi-discipline cross-functional project team environment

In addition to the core responsibilities outlined above, an opportunity exists to collaborate across our Research & Development Division with automation and digital initiatives and to contribute towards defining/streamlining various business processes for efficient and flexible GMP clinical supply for products in all phases of development. Some off shift (second shift and weekends) will be required to support campaigns.  

Education Minimum Requirement:

Bachelor’s degree in engineering or computer science with a minimum of 5 years of relevant automation experience.

Required Experience and Skills:

• Highly motivated with the ability to work in a fast-paced and dynamic setting.
• Strong organizational, planning, and communication skills.
• Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines.  This includes executing GMP change controls.
• Significant experience in one or more of the following automation technologies:  DeltaV, Ignition, PLC/SCADA.
• Ability to work independently and in a team environment

Desired Experience and Skills:

• Experience with manufacturing equipment, process control, automation infrastructure design, and/or cybersecurity
• Experience with integrating equipment automation systems with Enterprise IT managed systems (e.g. MES, virtualization, networking, windows and antivirus patching/updates)
• Experience with Project Management Methodologies (Agile, Waterfall, etc) and Tools (Jira/Confluence, RACI, GANTT)

Required Skills:

Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Applications are being sought for an Engineering Specialist position in our Company's Research & Development division Biologics Pilot Plant (BPP) automation engineering group.  Individual will perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.

Candidate will participate in a range of activities including, but are not limited to:

• Providing ongoing automation system support and executing projects in the facility, with progression to leading those projects
• Participating in the design, scope, implementation, and maintenance of pilot plant projects
• Actively working in a multi-discipline project team environment
• Developing and maintaining SDLC documentation.
• Participating/leading in the troubleshooting of various automation system technologies
• Participating/leading in upgrade and ongoing maintenance projects on systems in the facility.
• Cross training in a variety of technologies
• Supporting automation needs across the facility
• Working with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant’s reliability and increase efficiency

In addition to the core responsibilities outlined above, an opportunity exists to contribute towards digital initiatives to support efficient and flexible GMP clinical supply for products in all phases of development. Some overtime (including weekends) and occasional second shift work may be required.  

Education Minimum Requirement:

• Bachelor’s degree in engineering or computer science with at least 2 full years of relevant experience, or at least 1 year of experience with a master’s degree.

Required Experience and Skills:

• Previous experience with industrial automation system configuration or programming at a production or lab scale
• Strong organizational, planning, and communication skills
• Ability to work both in a team setting and independently

Desired Experience and Skills:

• Experience in a GMP regulated industry
• Knowledge in any of the following: Systems communication/integration, DeltaV, Ignition, PLC’s, Unicorn, manufacturing IT, process/system control, systems communication (interfaces)
• Experience with production equipment

Required Skills:

Adaptability, Adaptability, Automation Engineering, Automation Framework Design, cGMP Guidelines, Computer Science, Electronic Batch Records, GMP Compliance, Industrial Automation, Innovation, Laboratory Experiments, Mammalian Cell Culture, Manufacturing, Medical Supplies, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Development, Product Formulation, Product Lifecycle, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Systems Troubleshooting, Teamwork {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DS organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities

• Lead and engage with the engineering design firms in detailed design on all aspects of drug substance manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug substance area.
• Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
• Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
• Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
• Provide technical leadership for new product introductions (Tech Transfer).
• Support technical deliverables within Drug Substance to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required

• Bachelor’s degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
• Ability to adapt to changing priorities as project demands change.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred

• Start-up experience in a large-scale commercial drug substance facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
• Expertise in chromatography and TFF operations will be advantageous.
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.

Required Skills:

Antibodies, Antibodies, Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Request Management, Chemical Process Development, Chromatography, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Deviation Management, Equipment Qualification, Factory Acceptance Test (FAT), GMP Compliance, Hazard Analysis, Immunochemistry, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements {+ 8 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DP organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities

• Lead and engage with the engineering design firms in detailed design on all aspects of drug product manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug product area.
• Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
• Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as formulation, filling, isolators, lyophilization and aseptic processing.
• Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
• Provide technical leadership for new product introductions (Tech Transfer).
• Support technical deliverables within Drug Product to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required

• Bachelor’s degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches, engineering batches, developmental batches and PPQ runs.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred

• Start-up experience in a large-scale commercial drug product facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
• Expertise in drug product filling and lyophilization operations will be advantageous.
• Previous experience with CQV activities will be advantageous.

Required Skills:

Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Management, Change Request Management, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Equipment Qualification, GMP Compliance, Hazard Analysis, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Pharmaceutical Manufacturing, Process Characterization, Process Hazard Analysis (PHA), Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements, Results-Oriented {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Description

Our company is currently seeking an exceptional chemist for a group leader position within the Process Chemistry Department located at our Rahway, NJ site. A successful candidate will be joining a group of innovative laboratory scientists with broad deliverables ranging from the design of manufacturing routes for drug candidates to executing and coordinating deliveries of active pharmaceutical ingredient to support our company's pipeline and products. We are looking for a team player with strong leadership skills and ability and passion for mentoring and working along others in a laboratory setting. The candidate will work closely within multidisciplinary teams comprised of synthetic organic chemists, engineers, and external research partners

(both academic and industrial). A Ph.D. in chemistry or related discipline with a demonstrated ability for taking initiative and innovative problem solving is critical. A successful candidate is expected to apply cutting edge methodologies into synthetic routes to accelerate deliveries of active pharmaceutical ingredient to support pre-clinical and clinical studies. An established excellent reputation for scientific excellence supported by publications and external presentations is expected. Candidates must possess strong written and oral communication skills and the ability to drive results as a team leader.

Education Minimum Requirement

Ph.D. in Organic Chemistry or related discipline

Required Experience and Skills

• Minimum 7 years of experience with a proven track record of successful research in process chemistry
• Must have a strong track record of delivering results via innovation and fearless problem solving.
• Broad expertise in organic synthesis and experience in pharmaceutical process chemistry and adjacencies
• Demonstrated ability for taking initiative, creativity and innovation in problem solving
• Productivity and efficiency working in the laboratory
• Strong written and oral communication skills
• Excellent collaboration skills
• Established scientific reputation supported by publications and external presentations

Required Skills:

Academic Presentations, Accountability, Bioconjugation, Computational Chemistry, Creativity, Data Analysis, Deep Learning, High-Throughput Experimentation (HTE), Machine Learning (ML), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/28/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description

Senior Specialist, Engineering – GES Tech Center

Level – P3

Global Engineering Solutions (GES) is responsible for the design, construction, and delivery of advanced manufacturing facilities and laboratories worldwide. We provide premier engineering solutions in the pharmaceutical industry through technical innovation and project management to deliver important life-saving medicines and vaccines to patients. With our extensive range of facilities and environments, our Engineers have opportunities to impact Large and Small Molecule areas within our company's Manufacturing Division and Animal Health division lines of business, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Our Engineers provide solutions for internal and external manufacturing needs in support of operational efficiencies, continuous improvement, and innovations.

Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. The Senior Specialist operates under the guidance of the GES Process Lead and is part of a high performing team accountable for implementation of this major project within our Company's growing portfolio of Animal Health work. The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. The Senior Specialist would be responsible for leading the planning, design, and implementation of engineering solutions on a suite team. Core work includes equip/scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, technology transfer, construction support, equipment qualification, facility start-up and process demonstrations.

Preferred candidates will possess experience with engineering design, equipment operation, startup, and troubleshooting, and C&Q activities. They should demonstrate a proven aptitude for leading project design endeavors and offering creative solutions that align with business objectives. Additionally, the role may involve supervising junior engineers and collaboration with resources from an engineering firm.  Previous managerial experience in a similar position is desirable.

The Senior Specialist primary responsibility entails:

• Exhibiting strong technical/engineering leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.
• Leading a cross functional suite team of 5-10 members through the stage gates of a project and setting them up for success with knowledge transfer.
• Ensuring deliverables conform to our standards and practices; and are technically sound.
• Providing technical guidance during project implementation, assures viability of technology to meet design intent.
• Collaborating with other technical functions to ensure successful technology transfers of new and in-line products.
• Flexibility with travel up to 50%.

Job Description in Primary Posting Language

• This position will function as the technical/engineering process engineer with prior experience supporting Biologics, Vaccine and/or Sterile Projects.

Education Minimum Requirement:

• B.S. degree in Engineering (Chemical or Mechanical) or Science is required.  An advanced degree in Engineering, Science, or Business is preferred.

Required Experience and Skills:

• Minimum five (5) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design,  Capital Project implementation, Technical Operations, or Operations/EMU.
• 3+ years experience leading cross functional teams in the startup and C&Q execution of capital projects.
• Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
• Understanding of unit operations specific to vaccine/biologic manufacturing, including hygienic design and aseptic requirements for Buffer Prep, Formulation, and CIP/SIP and experience with primary and secondary packaging operations.
• Experience with capital projects that followed a stage gate capital management process.
• Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills.
• Analytical and problem-solving skills.
• Multitasking/time management skills which deliver on time and quality work.
• Core knowledge should include specification of unit operations, P&ID reviews, Hazard Analysis, equipment operation, commissioning & qualification execution.
• Work independently and meet timelines in a fast-paced team-based environment.
• Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.

Required Skills:

Adaptability, Capital Projects, Change Control Processes, Collaborative Communications, Construction, Customer-Oriented, Engineering Standards, Equipment Commissioning, Equipment Specifications, Global Engineering, Good Manufacturing Practices (GMP), Knowledge Transfer, Maintenance Engineering, Manufacturing Process Validation, Multitasking, Process Optimization, Project Implementations, Project Management, Self Motivation, Strategic Thinking, Teamwork, Technical Support, Technical Transfer, Working Independently

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

We anticipate the application window for this opening will close on - 20 May 2026 Position

Description

Responsible for the design, development, user validation and implementation of a complex PLM (including PDM Capabilities) across the enterprise and its integration with other systems like SAP. Coordinate the Product DNA initiative across the Medtronic enterprise, aimed at simplifying the creation, management, and utilization of product data. Establish a foundational, connected digital thread of product information by streamlining systems across the organization and implementing best-in-class practices and procedures. Utilize DMAIC (Define, Measure, Analyze, Improve, and Control) & DRM (Design, Reliability, and Manufacturability) methodology and Six Sigma to suggest design, development or manufacturing process improvement. Coordinate requirement flow-down process and requirement traceability utilizing requirement tools to include Cognition Cockpit and ability to develop the templates for flow-down. Responsible for leading and facilitating Agile development and deployment processes by managing cross-functional collaboration, prioritizing backlogs, ensuring quality delivery, and fostering continuous improvement to achieve project goals efficiently. Responsible for driving systems engineering excellence through continuous improvement, innovative problem-solving, and leading change initiatives to enhance organizational performance and efficiency. Conduct root-cause analysis into product and process failures and recommend corrective actions to prevent recurrence. Responsible for implementing Model-Based Systems Engineering (MBSE) and SysML to develop, analyze, and optimize system designs, ensuring traceability, collaboration, and alignment with engineering objectives. Responsible for managing and optimizing interconnected tool ecosystems to ensure seamless integration, enhance workflows, and drive efficiency across cross-functional teams. Responsible for analyzing and optimizing system architectures and alternatives using Mode-Frontier to perform trade-off studies, ensure alignment with objectives, and provide data-driven recommendations. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications

Master's degree in mechanical engineering, electrical engineering, computer science or similar degree with an emphasis on Systems engineering. Requires Four (4) years of experience in Systems Engineering and Model Based Systems Engineering Theory and Implementation. Must possess at least four (4) years’ experience in each of the following: DMAIC & DRM methodology and Six Sigma; Flow-down process and requirement traceability; Agile methodologies, and AZDO for managing development and deployment; Implement systems engineering practices with a drive for continuous improvement; Investigation and root cause determination of Product & Process failures; Model Based Systems Engineering and SysML tools including EA, Magic Draw, Windchill Modeler; Multiple Tool Ecosystems, Inter-connected Tool Eco Systems, interface design and analysis; Analyze System Architectures and alternatives using Mode-Frontier; Demonstrated Participation and Presentation in INCOSE (International Council of Systems Engineering). Salary: $154,000 to $192,000 per year. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]

We anticipate the application window for this opening will close on - 28 May 2026 Position

Description

Design, develop, test, debug and implement operating systems components, software tools and utilities. Determine systems software design requirements. Ensure that system improvements are successfully implemented and monitored to increase efficiency. Generate systems software engineering policies, standards and procedures. Responsible for Software development in compliance with ISO 13485 and IEC 62304 standards including creation of design documentation. Coordinate risk strategies for medical devices in compliance with ISO 14971, including use of Failure Mode and Effects Analysis (FMEA) per IEC 60812. Utilize programing languages including C# and C++. Leverage MATLAB, Python, JavaScript, SQLite, MySQL, and WiX. Utilize Microsoft Application Lifecycle Mgmt. (ALM) services including Azure DevOps and Team Foundation Server. Responsible for the application of Artificial Intelligence and Machine Learning (AI/ML) to medical devices. Develop software for powered surgical equipment, intraoperative nerve monitors, or surgical navigation/medical imaging devices including MRI, CT, and X-Ray. Relocation assistance is not available for this position. *Position is required to be onsite at the Jacksonville, FL location 4 days per week. #LI-DNI.

Basic Qualifications

Bachelor’s degree in Software Engineering, Computer Science, Computational Science, Electronic Engineering or related engineering field and two (2) years’ experience as a software engineer or related occupation. Must possess at least two (2) years’ experience with each of the following: ISO 13485 and IEC 62304 including creation of design documentation; Risk mgmt. of medical devices, ISO 14971 and IEC 60812; C# and C++; MATLAB, Python, JavaScript, SQLite, MySQL, and WiX; ALM services including Azure DevOps and Team Foundation Server; Application of AI/ML to medical devices; and Developing software for powered surgical equipment, intraoperative nerve monitors, or surgical navigation/medical imaging devices for MRI, CT and X-Ray. Salary: $112,000 to $147,600 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]