Lead Sterile Process Engineer – GMP & Aseptic Innovator

Socket.dev; Rahway (NJ); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Sterile Process Engineer to lead transfer, scale-up and procedural development for sterile clinical drug product operations. You will collaborate with cross-functional teams to ensure quality and regulatory compliance on-site in New Jersey.

The role emphasizes leadership, strong communication, and experience with quality investigations, change management, and cGMPs to enable rapid, compliant manufacturing for the FLEx GMP facility within PSDD.

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

• Drive process tech transfer, scale-up activities and GMP documentation for sterile clinical drug product operations.
• Lead quality investigations and change management within sterile operations.
• Author Standard Operating Procedures (SOP) and current GMP documents.
• Collaborate with formulation scientists, engineers, operations staff and quality representatives to ensure quality and regulatory compliance.

Skills

Aseptic Processing

cGMP Guidelines

Electronic Batch Records

Laboratory Experiments

Pharmaceutical Regulatory Compliance

Pharmaceutical Sciences

Pilot Plant Operations

Process Engineering

Process Improvements

Standard Operating Procedure (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

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Sterile Process Engineer to lead transfer, scale-up and procedural development for sterile clinical drug product operations. You will collaborate with cross-functional teams to ensure quality and regulatory compliance on-site in New Jersey.

The role emphasizes leadership, strong communication, and experience with quality investigations, change management, and cGMPs to enable rapid, compliant manufacturing for the FLEx GMP facility within PSDD.