The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, includes a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational start-up phase. FLEx Sterile is positioned to play a pivotal role in delivering our clinical pipeline to patients worldwide, supporting a diverse range of product modalities including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). The facility supports the formulation and filling of clinical and developmental sterile products for critical program needs, such as new products in process development, products undergoing scale-up, launch and transfer to the supply network, and existing commercial products undergoing process optimization. Support encompasses both start-up operations (FLEx Sterile1) and a new capital expansion (FLEx Sterile2).
The Specialist, Automation Engineering – role will provide end-to-end automation engineering support for the Rahway, NJ FLEx Center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences and Clinical Supply (PSCS), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures the reliable and compliant operation of process automation and OT/IT systems that enable formulation, filling, lyophilization, and associated support activities for clinical and development sterile products. This position supports start-up operations and new capital investments in the clinical supply area, including automation lifecycle management, data and analytics, and site representation on capital projects. Off-shift (second shift and weekend) or extended shift work will be required on an intermittent basis to support manufacturing operations. This role will be an onsite automation support role and directly reports to the Rahway FLEx Sterile Pharmaceutical Operations Engineering automation lead.
Primary Responsibilities:
Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)
Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements
Implement and sustain platform automation solutions, reporting, and visualization to meet operational and compliance needs; keep documentation, SOPs, drawings, configurations, PMs, and inventories inspection ready.
Lead and participate in automation system changes, investigations, CAPAs; represent automation and data integrity during internal/external audits and inspections.
Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
Serve as site automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive continuous improvement.
Represent automation in capital projects, embedding OT/IT architecture, cybersecurity, data integrity, and validation requirements in project scope and deliverables.
Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification (AIOQ) of new automated equipment and systems; author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.
Evaluate and plan automation/IT expansions, replacements, upgrades, and obsolescence remediation to ensure quality, stability, scalability, and supportability.
Partner with enterprise/divisional IT, global infrastructure, and risk/security to align standards and manage user/role administration, patching, backups, disaster recovery, and virtualization in GMP operations.
Collaborate with GES, FM/GWES, Quality (product/equipment QA and digital data quality -DDQ), Manufacturing Operations, OEM vendors/system integrators to deliver reliable, compliant automation operations.
Supervise and coordinate contract engineers/vendors and manage workload and deliverables.
Develop and support data, reporting, analytics, and visualization solutions using historian/SCADA sources to monitor asset health and drive reliability improvements.
Troubleshoot across controls, instrumentation, electrical, software, and industrial networking layers; apply lean and continuous improvement principles to stabilize and optimize automation system performance.
Off‑shifts (second shift/weekend) or extended shift work may be required to provide automation support for manufacturing operations.
Education Minimum Requirement:
Bachelor’s degree in an Engineering, Science, Information Technology, or related field.
Minimum 2 years of experience in process automation or equivalent.
Demonstrated a strong performance record and have excellent project management skills.
Highly developed communication, teamwork skills.
Required Experience and Skills:
Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation principles for automation and computer systems.
Hands-on experience maintaining validated automation systems, executing change control, investigations/CAPA, periodic reviews, system administration (e.g., user/role management, patching, backups, virtualization), and cybersecurity within GMP operations.
Proficiency with PLC/SCADA and industrial networking fundamentals; ability to troubleshoot across controls, instrumentation, electrical, and software layers.
Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.
Proven root cause analysis and problem-solving skills; continuous improvement mindset.
Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting
Knowledgeable of S88 batch standards.
Experience in biologics, vaccine or bulk sterile manufacturing facilities is strongly preferred.
OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration
Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva)
Prior leadership of installation/integration/qualification of automated equipment; experience on capital projects in GMP environments
Familiarity with planning/scheduling practices, vendor management, and business/financial acumen for project delivery
Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting
Demonstrated experience supporting audits/inspections and authoring/reviewing SOPs, validation protocols/reports.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that when we follow the science, we can invent medicines and vaccines that make a meaningful difference for patients worldwide. We believe that a research-driven enterprise dedicated to world-class science can change lives.
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What you can expect:
Direct impact enabling sterile product development from lab to clinic through robust, compliant automation
Ownership across automation lifecycle, troubleshooting, and capital initiatives
Collaboration with world-class operations, quality, engineering, IT, and security teams
Who we are:
For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for:
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss it in more detail, please contact your HRBP or Talent Acquisition Advisor. #VETJOB #EBRG
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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:
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.
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
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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:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/9/2026
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.
