Manufacturing Manager Programs
Amgen
About the Role
Amgen is seeking a Manufacturing Manager Programs – Cleaning Validation for its new, advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This role will serve as a technical lead and subject matter expert (SME) responsible for developing and implementing the validation strategy at the Amgen North Carolina (ANC) manufacturing facility.
Key Responsibilities
- Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program.
- Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities.
- Collaborate with project leads on validation outputs for commissioning and qualification of manufacturing process equipment.
- Supply cleaning/sterilization validation expertise, including generation/review/approval of cleaning-related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports).
- Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure Amgen validation requirements are met.
- Furnish technical assistance and represent validation for regulatory filings, audits, and inspections.
- Ensure maintenance of the site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems.
- Support site/network validation-driven continuous improvement initiatives.
- Serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy.
- Develop and generate documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports.
- Complete landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.
Requirements & Tech Stack
- Validation Master Plan
- Equipment Qualification Protocols/Reports
- Autoclave performance qualification
- Cleaning validation
- Validation maintenance
- Sterilization program
- Commissioning
- Qualification
- Cleaning/sterilization validation
- Validation maintenance activities
- Manufacturing process equipment
- Cleaning characterization/inactivation reports
- Acceptance limits reports
- Regulatory filings, audits, and inspections
- Site validation master plan
- Validation status/regulatory compliance of equipment and systems
- Site/network validation driven continuous improvement initiatives
- Eudralex Annex 15
- FDA Title 21 CFR Part 210 and 211
- Guidelines ASTM E2500
- ICH Q7
- Regulatory submissions
- Response to submission questions
- Pre-approval/biennial inspections
- Observational response plans
- Steaming validation
- Controlled temperature chambers (CTC)
Qualifications
- Doctorate degree OR
- Master’s degree and 3 years of Validation or Engineering experience OR
- Bachelor’s degree and 5 years of Validation or Engineering experience OR
- Associate’s degree and 10 years of Validation or Engineering experience OR
- High school diploma/GED and 12 years of Validation or Engineering experience
- In addition to the above, experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with required technical experience.
Preferred Qualifications
- Experience managing staff executing technical skills in a safe and compliant manner.
- Proficient technical writing and presentations skills.
- Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility.
- Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration.
- Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC).