Sterile Process Engineer - Associate (GMP)

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

Job summary

Merck & Co. in Rahway, NJ seeks a technically skilled professional to support sterile formulation, filling, lyophilization, and related manufacturing operations. You will contribute to process development, tech transfer, and regulatory readiness in a multi‑modality clinical production setting.

The role emphasizes GMP compliance, cross‑functional collaboration, and hands‑on equipment support in a controlled environment, with opportunities for growth and advancement.

Qualifications

• Knowledge of Good Manufacturing Practice principles and safety requirements.
• Strong problem‑solving and organizational skills, with the ability to work independently.
• Ability to communicate and work in partnership with other employees in a manufacturing environment.
• Ability to prepare Standard Operating Procedures and current GXP documents.
• Excellent verbal and written communication skills.
• Proficiency with MS Office, HMIs, SAP, and calibration databases.
• Lift up to 50 lbs; wear cleanroom PPE including respirators; work in Grade C cleanrooms.

Responsibilities

• Provide technical support for formulation, process development, scale-up, and technology transfer activities.
• Draft and maintain investigations, change controls, SOPs, batch docs, and technical protocols.
• Support commissioning, qualification, and regulatory readiness activities for the sterile facility.
• Troubleshoot aseptic formulation, filling, and lyophilization equipment across lifecycle.
• Manage assigned technical work and contribute to facility and process improvements.
• Assist with data review, technical assessments, troubleshooting, and continuous improvement.

Skills

Aseptic Handling

Clinical Manufacturing

Driving Continuous Improvement

Engineering Standards

Equipment Qualification

GMP Compliance

Manufacturing Systems

Operations Support

Process Improvements

Technical Support

Education

Bachelor's degree in an engineering discipline or related technical field

Tools

SAP

Job description

Merck & Co. in Rahway, NJ seeks a technically skilled professional to support sterile formulation, filling, lyophilization, and related manufacturing operations. You will contribute to process development, tech transfer, and regulatory readiness in a multi‑modality clinical production setting.

The role emphasizes GMP compliance, cross‑functional collaboration, and hands‑on equipment support in a controlled environment, with opportunities for growth and advancement.