Sterile Process Engineer — GMP Specialist, On‑Site in NJ

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

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) plan

Medical, dental, vision coverage

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Sterile Process Engineer (Specialist level) to lead technical and strategic efforts in our FLEx GMP facility. The role drives process transfer, scale-up, investigations, and SOPs to ensure sterile clinical drug product quality.

You will collaborate with scientists, engineers, operations, and QA to enable rapid, compliant manufacturing. On-site position with competitive salary and bonus eligibility.

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027)

Responsibilities

• Demonstrates leadership, technical and communication skills to drive the success of the sterile clinical drug product operation.
• Supports sterile GMP facility through process tech transfer, scale-up activities, quality investigations, change management, and authoring SOPs and GMP protocols.
• Collaborates with formulation scientists, engineers, operations, and quality to ensure quality and regulatory compliance across the pipeline.

Skills

Aseptic Processing

cGMP Guidelines

Electronic Batch Records

Laboratory Experiments

Pharmaceutical Regulations

Pharmaceutical Sciences

Pilot Plant Operations

Process Engineering

Process Improvements

SOP Development

Sterile Manufacturing

Technology Transfer

Troubleshooting

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027)

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Sterile Process Engineer (Specialist level) to lead technical and strategic efforts in our FLEx GMP facility. The role drives process transfer, scale-up, investigations, and SOPs to ensure sterile clinical drug product quality.

You will collaborate with scientists, engineers, operations, and QA to enable rapid, compliant manufacturing. On-site position with competitive salary and bonus eligibility.