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Aseptic Officer

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Amgen

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Location:
United States , Thousand Oaks

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

114990.00 - 139433.00 USD / Year
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Job Description:

In this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own the Media Program for one of two isolator-based filling lines, lead observation and training efforts to sustain aseptic compliance, and partner cross-functionally with Quality, Validation, and Engineering to ensure sterility assurance standards are consistently met.

Job Responsibility:

  • Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and implementation of corrective and preventive actions (CAPAs)
  • 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 ensure alignment with current regulatory expectations and site standards
  • Partner closely 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 robust understanding and control of aseptic practices
  • Lead the Media Fills supporting the site’s 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, batch records, and contamination control strategy
  • Evaluate results, find opportunities for process or operator improvement, and ensure timely closure of associated investigations and CAPAs
  • 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 (e.g., EM, bioburden, or utility monitoring) as needed
  • 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
  • Actively participate in Lean Transformation and continuous improvement initiatives (e.g., SQDIP boards, Kaizen events, and Work Center Teams)
  • Use problem-solving and root-cause tools (5S, Fishbone, 5 Whys) to identify and implement improvements to aseptic performance and process control

Requirements:

  • Doctorate degree
  • Master’s degree and 2 years of operations or quality experience
  • Bachelor’s degree and 4 years of operations or quality experience
  • Associate’s degree and 8 years of operations or quality experience
  • High school diploma / GED and 10 years of operations or quality experience
  • 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
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible

Additional Information:

Job Posted:
January 07, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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