Sterile Process Engineering Specialist

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

Job summary

Merck in Rahway, NJ is seeking a Specialist Engineer to support FLEx Sterile GMP operations with a 12–18 month Durham, NC rotation. The role requires hands-on automation, process development, and quality-focused execution across filling, lyophilization, and equipment validation.

After the rotation, the position relocates to Rahway, NJ to sustain manufacturing readiness, ensure regulatory compliance, and lead cross-functional technical initiatives in sterile product manufacturing.

Qualifications

• BS degree in chemical/biochemical engineering or related sciences with 2+ years experience.
• Familiarity with GMP and safety regulations.
• Strong problem-solving and ability to work independently.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Serve as technical SME for formulation and scale-up activities.
• Author quality investigations, change controls, SOPs, and technical protocols.
• Lead commissioning, qualification, and regulatory certification for FLEx Sterile GMP facility.
• Collaborate with formulation scientists, engineers, quality representatives, and other team members to ensure GMP compliance.
• Work with aseptic drug product formulation, filling, and lyophilization equipment across the manufacturing cycle.
• Manage project assignments and assist with equipment innovation.

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 in Rahway, NJ is seeking a Specialist Engineer to support FLEx Sterile GMP operations with a 12–18 month Durham, NC rotation. The role requires hands-on automation, process development, and quality-focused execution across filling, lyophilization, and equipment validation.

After the rotation, the position relocates to Rahway, NJ to sustain manufacturing readiness, ensure regulatory compliance, and lead cross-functional technical initiatives in sterile product manufacturing.