Sterile Manufacturing Specialist | Process & Automation

Merck; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in Durham, NC seeks a Specialist Engineer to support commercial vaccine manufacturing with a Durham rotation and a future relocation to Rahway, NJ. The role covers formulation, filling, lyophilization, and automation support on site, with multi‑site collaboration and strict adherence to GMP standards.

The position requires hands‑on experience in sterile drug product operations, problem‑solving, and cross‑functional teamwork to drive quality and efficiency in a dynamic manufacturing

Qualifications

• GMP regulatory knowledge (US/EU) and safety compliance.

Responsibilities

• Serve as technical SME for formulation, process development, and scale‑up activities.
• Support manufacturing by authoring investigations, change controls, SOPs, and technical protocols.
• Lead validation activities including commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
• Collaborate with scientists, engineers, quality, and IT to ensure product quality and process rigor.
• Perform maintenance, troubleshooting, and support across the manufacturing cycle.

Skills

Electronic Batch Records

Equipment Maintenance

Process Engineering

Sterile Manufacturing

Root Cause Identification

Education

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

Tools

Automation systems

Job description

Merck in Durham, NC seeks a Specialist Engineer to support commercial vaccine manufacturing with a Durham rotation and a future relocation to Rahway, NJ. The role covers formulation, filling, lyophilization, and automation support on site, with multi‑site collaboration and strict adherence to GMP standards.

The position requires hands‑on experience in sterile drug product operations, problem‑solving, and cross‑functional teamwork to drive quality and efficiency in a dynamic manufacturing