Second-Shift Pharma Equipment Engineer (GMP)

MSD Malaysia; Rahway (NJ); On-site; USD 87,300 - 137,400; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and time off

Job summary

Merck & Co. in Rahway, NJ is seeking a Non-Sterile Specialist, Engineering to provide on-site engineering support for the FLEx center on the second shift, collaborating across Research Labs and Pharmaceutical Sciences for OSD processes.

The role involves maintenance, validation support, deviation investigations, GMP documentation, and coordination of equipment installation and commissioning, with emphasis on quality and regulatory readiness.

Qualifications

• Strong familiarity with quality, cGMP, safety, and environmental policies and procedures.
• Familiarity with oral solid dosage drug-product manufacturing equipment and processes.
• Experience with computerized maintenance and management systems (CMMS).
• Strong mechanical, electrical, and automation troubleshooting ability.
• Ability to flexibly adapt to workflow across quality and facility aspects.
• Effective organizational, communication, and technical writing skills.
• Strong computer skills.

Responsibilities

• Maintain facility, utilities, and manufacturing equipment in compliance with GMP and safety requirements while applying reliability maintenance best practices.
• Support equipment validation from commissioning through decommissioning; manage changes and periodic reviews.
• Investigate deviations, issue quality notifications, identify root causes, and develop CAPAs.
• Maintain GMP documentation and support clinical operations.
• Manage purchase orders, capital requests, and coordinate installation and commissioning of new equipment.
• Provide engineering and compliance support for non‑sterile process equipment and utilities, and act as a subject‑matter expert during regulatory interactions.
• Operate with minimal supervision and serve as a technical and compliance resource during second‑shift operations.

Skills

GMP compliance

CMMS

Electrical troubleshooting

Mechanical troubleshooting

Automation troubleshooting

Quality processes

Communication

cGMP

Education

Bachelor’s degree in engineering

Tools

SAP Plant Maintenance

eVal/Kneat

ProCal CCMS

CMMS systems

Job description

Merck & Co. in Rahway, NJ is seeking a Non-Sterile Specialist, Engineering to provide on-site engineering support for the FLEx center on the second shift, collaborating across Research Labs and Pharmaceutical Sciences for OSD processes.

The role involves maintenance, validation support, deviation investigations, GMP documentation, and coordination of equipment installation and commissioning, with emphasis on quality and regulatory readiness.