Aseptic Officer
Amgen
Full-time
Remote friendly (Thousand Oaks, CA)
United States
Operations
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Role Summary
Aseptic Officer at Amgen responsible for providing technical leadership and oversight of aseptic operations within a multi-product drug product manufacturing facility, ensuring compliance with cGMP through aseptic technique, media fill programs, and contamination control initiatives.
Responsibilities
- Aseptic Program Leadership
- Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and CAPA implementation.
- Coach and mentor operations personnel to strengthen aseptic practices and contamination control awareness.
- Author, review, and maintain aseptic-related SOPs, reports, and training materials to align with regulatory expectations and site standards.
- Partner with Quality Assurance, Validation, and other site Aseptic Officers for consistent execution and knowledge sharing.
- Represent Manufacturing during inspections, demonstrating understanding and control of aseptic practices.
- Media Fill Program Ownership
- Lead the Media Fills for one of two isolator-based filling lines.
- Author and implement media fill protocols, complete final reports, and perform data trending and risk analysis.
- Coordinate with Manufacturing, Quality, and Engineering to ensure alignment with aseptic design, batch records, and contamination control strategy.
- Evaluate results and identify opportunities for process or operator improvement; ensure timely closure of investigations and CAPAs.
- Contamination Control and Compliance Support
- Support contamination control initiatives and provide aseptic expertise in investigations, deviations, and change controls.
- Participate in data reviews and trending related to aseptic or microbiological quality indicators.
- Contribute to improvements in facility design, procedures, and behaviors to enhance aseptic performance and sterility assurance.
- Participate in audits, provide required information, and respond to findings as appropriate.
- Operational Excellence
- Participate in Lean Transformation and continuous improvement initiatives.
- Apply problem-solving tools to identify and implement improvements to aseptic performance and process control.
Qualifications
- Basic Qualifications:
- Doctorate degree
- Or Master’s degree with 2 years of operations or quality experience
- Or Bachelor’s degree with 4 years of operations or quality experience
- Or Associate’s degree with 8 years of operations or quality experience
- Or High school diploma / GED with 10 years of operations or quality experience
- Preferred Qualifications:
- 10+ years of biopharmaceutical or medical technology experience with increasing responsibility
- Bachelor’s or Master’s degree in Microbiology, Life Sciences, or related field
- Demonstrated expertise in aseptic processing, isolator operations, and media fill program management
- Experience supporting regulatory inspections and contamination control initiatives in sterile manufacturing
- In-depth understanding of cGMPs, aseptic technique, and sterility assurance principles
- Familiarity with microbiological investigations, environmental monitoring interpretation, and deviation management
Skills
- Aseptic processing and sterility assurance
- Media fill program management
- Regulatory inspections support
- Environmental monitoring and microbiological analysis
- CAPA investigation and root-cause analysis
- Cross-functional collaboration with Quality, Validation, and Engineering
- Problem-solving and Lean/continuous improvement