Process & Facility Engineer - GMP Scaleup (MACS)

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

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck & Co., Rahway, NJ, is seeking a Specialist - Process/Facility Engineer to join the MACS Operations Team. The role supports equipment design, commissioning, and startup for a new multi-modality drug substance facility, collaborating across R&D, Quality, and Safety to ensure timely, compliant manufacturing.

The position requires a chemical engineering background, experience in GMP environments, and strong problem-solving and SOP skills to drive project milestones and ensure successful

Qualifications

• GMP clinical or manufacturing facility experience
• GMP facility design, equipment start-up and/or qualification
• Small/large molecule drug substance process development
• Support compliance investigations and change management
• Familiarity with US and EU GMP and Safety compliance regulations
• Ability to convert drug-substance processes into executable steps
• Prepare SOPs and cGMP documents
• Strong communication and organizational skills

Responsibilities

• Assist in equipment and facility design, start-up, and qualification
• Contribute to system commissioning/qualification and critical activity workstreams
• Collaborate with development engineers, chemists, and safety representatives
• Ensure quality and safe delivery of clinical supplies and processes
• Lead or support qualification activities and tech transfer
• Participate in process development and regulatory documentation

Skills

cGMP Guidelines

Chemical Engineering

Electronic Batch Records

Facility Engineering

Pilot Plant Operations

Process Engineering

Quality Control Systems

Safety Compliance

SOP

Troubleshooting

Education

Bachelor's degree in Chemical Engineering

Master's degree in related field

Job description

Merck & Co., Rahway, NJ, is seeking a Specialist - Process/Facility Engineer to join the MACS Operations Team. The role supports equipment design, commissioning, and startup for a new multi-modality drug substance facility, collaborating across R&D, Quality, and Safety to ensure timely, compliant manufacturing.

The position requires a chemical engineering background, experience in GMP environments, and strong problem-solving and SOP skills to drive project milestones and ensure successful