Aseptic Officer

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 and media fill programs, and supporting contamination control initiatives across operations.

Responsibilities

• Aseptic Program Leadership
  • Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and CAPA implementation.
  • Provide coaching and mentoring to 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 to ensure consistent execution and knowledge sharing across functions.
  • Represent Manufacturing during internal and external inspections, demonstrating control of aseptic practices.
• Media Fill Program Ownership
  • Lead the Media Fills supporting one of two isolator-based filling lines.
  • Author and implement media fill protocols, complete final reports, and perform data trending and risk analysis.
  • Partner with Manufacturing, Quality, and Engineering to ensure execution aligns with aseptic process design and contamination control strategy.
  • Evaluate results, identify opportunities for improvement, and ensure timely closure of investigations and CAPAs.
• Contamination Control and Compliance Support
  • Support contamination and cross-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 that enhance aseptic performance and sterility assurance.
  • Participate in partner and regulatory audits, provide required information, and respond to findings as appropriate.
• Operational Excellence
  • Participate in Lean Transformation and continuous improvement initiatives (e.g., SQDIP boards, Kaizen events, Work Center Teams).
  • Use problem-solving and root-cause tools to identify and implement improvements to aseptic performance and process control.

Qualifications

• Basic Qualifications:
  • Doctorate degree
  • Or Master’s degree and 2 years of operations or quality experience
  • Or Bachelor’s degree and 4 years of operations or quality experience
  • Or Associate’s degree and 8 years of operations or quality experience
  • Or High school diploma / GED and 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 a 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

• Leadership and technical oversight in aseptic operations
• Strong collaboration with Quality, Validation, and Engineering
• Proficiency in data trending, CAPAs, and regulatory inspection readiness
• Experience with media fill protocols and aseptic process design
• Problem-solving using 5S, Fishbone, and 5 Whys