Specialist, Engineering (Onsite)

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

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

MSD is seeking a Non-Sterile Specialist, Engineering for Rahway, NJ on second shift. The role focuses on maintaining facilities, utilities and manufacturing equipment in compliance with GMP and safety, while applying Reliability Maintenance practices to support timely clinical and development batches.

Responsibilities include equipment validation, changes management, deviations investigations, and GMP documentation. Collaboration with QA, Facilities, OEMs and vendors is required.

Qualifications

• Bachelor’s degree in engineering; 2+ years in pharma manufacturing operations for OSD products preferred.
• Knowledge of cGMP, QA, safety policies and environmental procedures.
• Experience with CMMS and equipment maintenance processes.
• Strong troubleshooting: mechanical/electrical/automation.
• Ability to work across Quality and Facility domains and communicate clearly.

Responsibilities

• Maintain facility, utilities and equipment per GMP and safety requirements.
• Support equipment validation from commissioning to decommissioning.
• Manage changes, periodic reviews, deviations, NCs/CAPAs and GMP documentation.
• Coordinate installation and commissioning of new equipment and support regulatory interactions as SME.
• Assist in procurement, capital requests, and vendor coordination.

Skills

Adaptability

cGMP Guidelines

Electronic Batch Records

GMP Compliance

Process Optimization

SOP Writing

Education

Bachelor’s degree in engineering

Tools

SAP Plant Maintenance

eVal/Kneat

ProCal CCMS

CMMS

Job description

Job Description

Non-Sterile Specialist, Engineering

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.

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.

#eligibleforERP

#PSCS

FLEx2026

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. 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

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.

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

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*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.