Lead Sterile Process Engineer, GMP Drug Product

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

401(k) plan

Paid holidays

Vacation days

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Sterile Process Engineer at the Specialist level to lead sterile drug product operations, drive tech transfer, scale‑up, and SOP development for GMP clinical supply.

You will collaborate with formulation scientists, engineers, operations staff, QA, and other teams to ensure quality, scientific rigor, and timely delivery, reporting to the Sterile Process Engineering Lead of the FLEx facility.

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

• Lead sterile drug product operations and support tech transfer, scale‑up activities, and quality investigations
• Develop, review, and approve SOPs and current GXP documents
• Collaborate with formulation scientists, engineers, operations staff, and QA to ensure product quality and process rigor
• Support change management processes and regulatory compliance per US/EU GMP standards
• Drive continuous improvement initiatives and troubleshoot process issues

Skills

Aseptic Processing

cGMP Guidelines

Electronic Batch Records

Laboratory Experiments

Pharmaceutical Regulatory

Pharmaceutical Sciences

Pilot Plant Operations

Process Engineering

Process Improvements

SOP

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 is seeking a Sterile Process Engineer at the Specialist level to lead sterile drug product operations, drive tech transfer, scale‑up, and SOP development for GMP clinical supply.

You will collaborate with formulation scientists, engineers, operations staff, QA, and other teams to ensure quality, scientific rigor, and timely delivery, reporting to the Sterile Process Engineering Lead of the FLEx facility.