Aseptic Officer

Role Summary

Aseptic Officer at Amgen. Provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility, ensuring cGMP compliance through aseptic technique and media fill programs, and supporting contamination control initiatives. Own the media program for one of two isolator-based filling lines and collaborate with Quality, Validation, and Engineering to maintain sterility assurance standards.

Responsibilities

• Aseptic Program Leadership: lead the Aseptic Technique Program, perform routine observations, data trending, and manage CAPAs; coach operations personnel on aseptic practices; author and maintain aseptic SOPs, reports, and training materials; partner with QA, Validation, and other site Aseptic Officers; represent Manufacturing during inspections.
• Media Fill Program Ownership: lead media fills for one isolator-based filling line; author protocols, finalize reports, perform data trending and risk analysis; ensure alignment with process design and contamination control strategy; close investigations and CAPAs promptly.
• Contamination Control and Compliance Support: support contamination control initiatives, provide aseptic expertise in investigations, deviations, and change controls; participate in data reviews related to aseptic/microbiological indicators; contribute to improvements in facility design and procedures; participate in audits and respond to findings.
• Operational Excellence: participate in Lean Transformation and continuous improvement initiatives; apply root-cause tools to improve 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 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 a sterile manufacturing environment
  • In-depth understanding of cGMPs, aseptic technique, and sterility assurance principles
  • Familiarity with microbiological investigations, environmental monitoring data interpretation, and deviation management

Skills

• Aseptic processing and sterility assurance
• Media fill program management
• Regulatory inspections support
• Root-cause analysis and CAPA execution
• Cross-functional collaboration (Quality, Validation, Engineering)
• Data trending and interpretation of aseptic/microbial indicators