Sterile Process Engineer - Associate Specialist

Merck; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck in Rahway, NJ is seeking Associate Specialist candidates to join FLEx Tech Ops and FLEx Operations. The role focuses on providing technical support for sterile manufacturing processes, helping with change controls, documentation, and regulatory readiness as the facility moves toward startup.

The position requires a Bachelor’s degree in an engineering or related discipline with graduation by July 2027, and a strong GMP mindset.

Qualifications

• Bachelor’s degree in engineering or related discipline; pursuing degree and graduating by July 2027.
• Knowledge of GMP principles and safety requirements; learn and apply site procedures.

Responsibilities

• Provide technical support for formulation, process development, scale‑up, and technology transfer activities.
• Draft and maintain investigations, change controls, SOPs, batch documentation, and technical protocols.
• Support commissioning, qualification, and regulatory readiness activities for the FLEx Sterile facility.
• Assist with data review, troubleshooting, and continuous improvement.

Skills

GMP compliance

Problem solving

Communication

Microsoft Office

SAP

Equipment operation

Gowning/cleanroom

Team collaboration

Education

Bachelor’s degree in engineering or related discipline

Pursuing degree with graduation by July 2027

Tools

SAP

Calibration databases

Job description

Merck in Rahway, NJ is seeking Associate Specialist candidates to join FLEx Tech Ops and FLEx Operations. The role focuses on providing technical support for sterile manufacturing processes, helping with change controls, documentation, and regulatory readiness as the facility moves toward startup.

The position requires a Bachelor’s degree in an engineering or related discipline with graduation by July 2027, and a strong GMP mindset.