Specialist, Engineering (Onsite)

Merck; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays, vacation, sick days

Job summary

Merck in Rahway, NJ seeks an engineer to provide on-site support for the FLEx center, focusing on non-sterile operations. The role supports equipment and utilities, maintains GMP compliance, and works second shift with supervision minimal.

You will handle validation activities, CAPAs, and regulatory documentation. The candidate will coordinate changes, manage procurement, and assist in commissioning of new equipment.

Qualifications

• Bachelor’s degree in engineering and minimum 2 years of related experience supporting pharmaceutical manufacturing operations for oral solid dosage formats.
• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with OSD drug product manufacturing equipment and process.
• Familiarity with CMMS systems and validated equipment.
• Ability to troubleshoot mechanical, electrical, and automation issues.
• Ability to work across Quality and Facility areas to support business.
• Effective organizational and communication skills.

Responsibilities

• Maintain facility, utilities, and manufacturing equipment in GMP compliance.
• Provide reliability maintenance and comply with safety requirements.
• Troubleshoot equipment and support non-sterile process equipment and utilities.
• Support equipment validation from commissioning through decommissioning and manage changes.
• Investigate deviations, issue Quality Notifications, determine root causes and CAPAs.
• Prepare GMP documentation and support regulatory interactions as SME when needed.
• Coordinate installation, commissioning, and capital project activities.
• Manage POs and capital requests and support clinical operations.

Skills

Adaptability

Biopharmaceuticals

cGMP Guidelines

Electronic Batch Records

GMP Compliance

Laboratory Experiments

Mammalian Cell Culture

Pharmaceutical Biology

Pharmaceutical Manufacturing

Pharmaceutical Sciences

Pharmacodynamics

Pharmacotherapeutics

Process Optimization

Product Formulation

SOP Writing

Education

Bachelor’s degree in engineering

2 years related experience in pharma manufacturing

Tools

CMMS

SAP Plant Maintenance

eVal/Kneat

ProCal CCMS

Job description

Position Summary

This Engineer position provides on-site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift), Monday through Friday, is required to meet operational needs.

Job Description

The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products, including process development, scale‑up, launch and transfer to the supply network, and process optimization for commercial products.

The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements while applying Reliability Maintenance best practices to support timely availability of clinical and development batches. This includes troubleshooting equipment, partnering with GES, Facilities Management, OEMs, and vendors, and providing engineering and compliance support for non‑sterile process equipment and utilities.

The role operates with minimal supervision and serves as a technical and compliance resource during second shift operations. Responsibilities include supporting equipment validation from commissioning through decommissioning, managing changes and periodic reviews, investigating deviations, issuing Quality Notifications, identifying root causes and CAPAs, maintaining GMP documentation, supporting clinical operations, managing purchase orders and capital requests, coordinating installation and commissioning of new equipment, and supporting regulatory interactions as an SME when needed.

Education

• Bachelor’s degree in engineering plus a minimum of 2 years of related experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats.

Required Experience And Skills

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.


• Familiarity with Oral Solid Dosage (OSD) 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.

Required Skills

Adaptability, Biopharmaceuticals, cGMP Guidelines, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Pharmaceutical Biology, Pharmaceutical Manufacturing, Pharmaceutical Sciences, Pharmacodynamics, Pharmacotherapeutics, Process Optimization, Product Formulation, Standard Operating Procedure (SOP) Writing

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. We ensure an accessible hiring process for all candidates.

Requirements

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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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

Salary

The salary range for this role is $87,300.00 - $137,400.00. This is the lowest to highest salary we 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.

Benefits

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.

Application Deadline

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

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

09/25/2026

Job Posting Validity

• 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.

Requisition ID

R407653