Onsite Sterile Process Engineer, Senior Specialist
MSD
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Job summary
MSD in Rahway, New Jersey seeks a Senior Specialist Sterile Process Engineer to drive process development, tech transfers, and quality investigations for sterile clinical drug products at the FLEx Center.
You will collaborate with development scientists, engineers, operations, and quality, author SOPs, and ensure regulatory compliance while supporting on-site manufacturing in New Jersey. This role reports to the Sterile Process Engineering Lead.
Qualifications
- Bachelor's degree or higher in a related scientific field with several years of relevant experience.
- Advanced degrees preferred for higher-level responsibilities.
- Experience leading sterile GMP-related activities is desirable.
Responsibilities
- Lead process transfers and scale-up activities for sterile clinical drug products.
- Drive investigations and change management to ensure compliant operations.
- Author and maintain SOPs and GXP documents for sterile operations.
- Collaborate with development scientists, engineers, operations, and quality to ensure product quality and process rigor.
- Report to Sterile Process Engineering Lead and support on-site facility operations in Rahway, NJ.
Skills
Education
Job description
MSD in Rahway, New Jersey seeks a Senior Specialist Sterile Process Engineer to drive process development, tech transfers, and quality investigations for sterile clinical drug products at the FLEx Center.
You will collaborate with development scientists, engineers, operations, and quality, author SOPs, and ensure regulatory compliance while supporting on-site manufacturing in New Jersey. This role reports to the Sterile Process Engineering Lead.
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