Sterile Process Engineer – GMP & Automation
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. is seeking a Specialist Engineer to support commercial drug product manufacturing operations at the Durham, NC site with a 12–18 month rotation before relocation to Rahway, NJ.
The role requires on-site presence and involvement in formulation, filling, lyophilization, and inspection processes. Responsibilities include troubleshooting, deviation investigations, change controls, equipment validation, and collaboration with formulation scientists, engineers, and quality teams to ensure
Qualifications
- BS degree with minimum 2 years of relevant experience.
- Familiarity with US/EU GMP and safety regulations.
- Strong problem-solving, organizational, and cross-functional collaboration skills.
Responsibilities
- Support shop floor equipment and automation troubleshooting.
- Investigation support for deviations and change controls.
- Author quality investigations, SOPs, and technical protocols.
- Lead commissioning, qualification, and regulatory certification activities for sterile manufacturing.
- Maintain GMP documentation and support automation and data integrity.
Skills
Education
Job description
Merck & Co. is seeking a Specialist Engineer to support commercial drug product manufacturing operations at the Durham, NC site with a 12–18 month rotation before relocation to Rahway, NJ.
The role requires on-site presence and involvement in formulation, filling, lyophilization, and inspection processes. Responsibilities include troubleshooting, deviation investigations, change controls, equipment validation, and collaboration with formulation scientists, engineers, and quality teams to ensure
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