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Sr. Associate Manufacturing Production Process Owner

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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:

92002.00 - 108605.00 USD / Year
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Job Description:

In this vital role you will partner with cross-functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life-changing therapies to patients worldwide.

Job Responsibility:

  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
  • Support timely investigation and resolution of manufacturing deviations
  • Participate in root cause analyses (RCA) and human performance evaluations
  • Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness
  • Assist in developing and executing process validation protocols and reports
  • Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance
  • Support establishment of process parameters, control limits, and performance reporting
  • Support change control activities to ensure GMP, regulatory, and operational compliance
  • Evaluate and justify process or equipment changes and assist with project execution
  • Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations

Requirements:

  • High school/GED + 4 years Manufacturing support experience
  • Associate’s + 2 years Manufacturing support experience
  • Bachelor’s + 6 months Manufacturing support experience
  • Master's
  • Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
  • Experience in aseptic Drug Product or biologics manufacturing
  • Knowledge of process validation, deviation management, and change control
  • Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
  • Excellent written and verbal communication skills and ability to collaborate across functions

Nice to have:

  • Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
  • Experience in aseptic Drug Product or biologics manufacturing
  • Knowledge of process validation, deviation management, and change control
  • Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
  • Excellent written and verbal communication skills and ability to collaborate across functions
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 where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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