Manufacturing Systems Engineer I — Validation Lead
Initial Therapeutics, Inc.
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Benefits offered by this job
Job summary
Amgen North Carolina facility seeks an Associate Manufacturing Systems Engineer I to lead the development and implementation of validation strategies for manufacturing process equipment and autoclave performance. You will generate Validation Master Plans, qualification protocols/reports, and drive improvement across commissioning, cleaning, and validation maintenance.
The role requires collaboration with Manufacturing, Engineering, Quality, and Process Development to meet validation requirements
Qualifications
- Bachelor's degree or equivalent in manufacturing/engineering with relevant experience.
- Experience with validation, commissioning, qualification, and clean validation.
- Ability to read and interpret P&IDs and regulatory documents.
Responsibilities
- Develop and implement the Validation Master Plan and related documents.
- Lead commissioning, qualification, cleaning validation, and validation maintenance activities.
- Coordinate validation efforts with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
- Review validation protocols/reports for equipment commissioning and change control.
- Support continuous improvement initiatives in validation programs.
Skills
Education
Tools
Job description
Amgen North Carolina facility seeks an Associate Manufacturing Systems Engineer I to lead the development and implementation of validation strategies for manufacturing process equipment and autoclave performance. You will generate Validation Master Plans, qualification protocols/reports, and drive improvement across commissioning, cleaning, and validation maintenance.
The role requires collaboration with Manufacturing, Engineering, Quality, and Process Development to meet validation requirements
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