Sterile Engineer, Specialist (On-site)

Job Description

Job Description

 

This Engineer position will provide on-site engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, for sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).  Pharm Ops Engineering is responsible for providing technical support across quality engineering, equipment reliability and maintenance, and sterilization and cleaning validation to ensure safe, compliant, and reliable operations.

The FLEx facility supports the formulation and aseptic filling of clinical, stability, and developmental sterile products, including key programs advancing through process development, scale-up, launch, technology transfer, and commercial process optimization.

This position primarily supports the FLEx Sterile 2 manufacturing area, with secondary support responsibilities for FLEx Sterile1.  FLEx Sterile1 is currently operational, while FLEx Sterile2 is under construction as part of a major capital project, with a target Ready-for-Science date of Q1 2030.  This position is primarily intended for 1st shift, but batch activity may necessitate some off-shift support.

The incumbent provides engineering support for Quality Engineering (QE), capital projects, equipment reliability, and sterile validation programs supporting the FLEx Sterile manufacturing facilities. This role partners closely with Operations, Quality, Engineering, Maintenance, Global Engineering Services (GES), Facilities Management (FM/GWES), OEMs, and external vendors to support ongoing operations, facility upgrades, and the installation, commissioning, qualification, and lifecycle management of manufacturing equipment and utility systems.

Key responsibilities include supporting the full equipment lifecycle from commissioning through decommissioning; authoring, executing, reviewing, and approving qualification and validation documentation; managing equipment and system changes; conducting periodic reviews; supporting investigations, deviations, Quality Notifications (QNs), and CAPAs; and maintaining GMP engineering documentation and asset records. The role applies reliability-centered maintenance principles to ensure equipment availability and support the timely manufacture of clinical, stability, and developmental products.

The position also serves as a Subject Matter Expert (SME) for sterilization and cleaning validation programs. Responsibilities include developing and maintaining validation strategies, SOPs, protocols, and reports; performing technical assessments; coordinating validation activities with third-party service providers; troubleshooting technical issues; and ensuring compliance with GMP, safety, and regulatory requirements.

Additional responsibilities include contractor and vendor oversight, work order governance, purchase order and budget support, asset management, capital project administration, equipment startup activities, and regulatory inspection support. Success in this role requires strong technical expertise, cross-functional collaboration, problem-solving skills, and the ability to support both operational and project-based objectives within a regulated pharmaceutical manufacturing environment.

 

Education Minimum Requirement: 

• Bachelor's degree in engineering or science plus a minimum of 2 years of related Drug Product/Sterile/Validation experience.

Required Experience and Skills: 

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Sterile Drug Product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS). 
• Troubleshooting ability (mechanical/electrical/automation)
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.  
• Effective organizational skills. 
• Effective communication and technical writing skills.
• Strong computer skills

 

Preferred Experience and Skills: 

• Maintenance & Engineering techniques and management and Capital Project management. 
• Independent problem- solving.
• SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
• eVal/Kneat  - Paperless electronic validation system
• Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with Planning and Scheduling practices as well as business/financial practices. 
• The candidate should be able to work independently and lead or facilitate tasks successfully.

 

EligibleforERP

Required Skills:

Capital Project Management, cGMP Guidelines, Cleaning Validations, Clinical Manufacturing, Engineering Support, Equipment Management, Maintenance Management Systems, Pharmaceutical Sciences, Pilot Plant Operations, Quality Engineering, Regulatory Requirements, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

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:

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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

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

11/17/2026

*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.