Sterile GMP Engineer – Onsite Manufacturing

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

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) plan

Healthcare benefits

Job summary

Merck & Co., Inc. in Durham, NC and Rahway, NJ, seeks a Specialist Engineer to support FLEx Sterile operations. The role starts in Durham for 12–18 months, then relocates to Rahway to bolster sterile drug product manufacturing, filling, lyophilization, and related utilities.

You will collaborate with formulation scientists, quality, and engineers to ensure GMP compliance, author investigations, change controls, and technical protocols, while maintaining equipment qualification and readiness.

Qualifications

• Familiarity with United States and European Union GMP and safety compliance regulations.
• Strong problem-solving skills and ability to work independently.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Ability to collaborate effectively with cross-functional teams and stakeholders.
• Excellent verbal and written communication skills.

Responsibilities

• Serve as technical SME for formulation, process development, and scale-up activities at FLEx operations.
• Support manufacturing by authoring investigations, change controls, SOPs, and technical protocols for clinical drug product operations.
• Contribute to commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
• Collaborate with formulation scientists, quality, and engineers to ensure GMP compliance and operational readiness.

Skills

Electronic Batch Records

Equipment Maintenance

Operation Maintenance

Pilot Plant Operations

Process Engineering

Process Manufacturing

Product Formulation

Root Cause Identification

Sterile Manufacturing

Troubleshooting

Education

B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines

Job description

Merck & Co., Inc. in Durham, NC and Rahway, NJ, seeks a Specialist Engineer to support FLEx Sterile operations. The role starts in Durham for 12–18 months, then relocates to Rahway to bolster sterile drug product manufacturing, filling, lyophilization, and related utilities.

You will collaborate with formulation scientists, quality, and engineers to ensure GMP compliance, author investigations, change controls, and technical protocols, while maintaining equipment qualification and readiness.