Pharma Facilities Engineer - 2nd Shift

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

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.