Associate Manufacturing Validation Engineer
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Benefits offered by this job
Job summary
Amgen North Carolina manufacturing facility seeks a technical lead/SME to develop and implement the Validation strategy. You will generate Validation Master Plans, qualification protocols, and reports, driving autoclave qualification, cleaning validation, and ongoing maintenance activities.
You will collaborate with Manufacturing, Engineering, Quality, and Process Development to ensure comprehensive validation across equipment and processes, while supporting continuous improvement and technical
Qualifications
- High school diploma / GED or higher with manufacturing/operations experience
- Associates degree with manufacturing/operations experience
- Bachelor's degree in a related field or equivalent experience
- Technical writing and presentation skills are a plus
- Experience with cleaning validation and equipment qualification is preferred
Responsibilities
- Develop and implement the Validation strategy for ANC manufacturing
- Create and maintain Validation Master Plan, validation plans, reports
- Lead autoclave performance qualification and cleaning validation landmarks
- Collaborate with Manufacturing, Engineering, Quality and Supply Chain
- Support continuous improvement initiatives in validation processes
Skills
Education
Tools
Job description
Amgen North Carolina manufacturing facility seeks a technical lead/SME to develop and implement the Validation strategy. You will generate Validation Master Plans, qualification protocols, and reports, driving autoclave qualification, cleaning validation, and ongoing maintenance activities.
You will collaborate with Manufacturing, Engineering, Quality, and Process Development to ensure comprehensive validation across equipment and processes, while supporting continuous improvement and technical
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