Specialist - Manufacturing - Engineering Support
Amgen Inc
Amgen seeks a manufacturing engineering specialist to support pharmaceutical operations in New Albany, Ohio. The role involves developing technical documentation, managing quality records, and collaborating across departments to maintain GMP compliance in a biotech manufacturing environment.
Responsibilities
- Develop and update SOPs, work instructions, protocols, and technical reports for manufacturing processes
- Generate and manage quality records including deviations, CAPAs, and change controls
- Support manufacturing team with documentation preparation, data collation, and tracking
- Collaborate with cross-functional departments on training documentation and process improvements
- Liaison with Quality Assurance to ensure GMP standards compliance
Requirements
- Doctorate degree, or Master's degree with 2+ years pharma/biotech experience
- Bachelor's degree with 4+ years manufacturing or quality experience
- Associate's degree with 8+ years relevant industry experience
- High school diploma with 10+ years engineering or quality experience
- Experience in GMP environments and technical writing
- Strong problem-solving and troubleshooting skills
- Ability to communicate complex technical information clearly
Vacancy posted 8 days ago
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