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Principal Engineer - Combination Product Operations MSAT Primary Container Engineering/SRE

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Amgen

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Location:
United States , Thousand Oaks

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Category:
-

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Contract Type:
Not provided

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Salary:

152579.00 - 179873.00 USD / Year
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Job Description:

In this vital role you will act as a cross-functional leader in Combination Product Operations (CPO) and work with internal and external teams to support the commercialization of Amgen products around the globe.

Job Responsibility:

  • Lead technical coordination with key primary component suppliers
  • Lead primary component improvement projects related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
  • Development and management of Integrated Project Plans and program dashboards/communications
  • Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products
  • Support integration of primary containers into new and existing devices/combination products
  • Support on-going Deviation/CAPA and Change Control processes
  • Support development of characterization methods for mechanical and physical properties of primary components
  • Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc.
  • Develop and share best practices and tools

Requirements:

  • High school diploma / GED and 12 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry
  • Associate’s degree and 10 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry
  • Bachelor’s degree and 6 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry
  • Master’s degree and 4 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry
  • Doctorate degree and 2 years of Mechanical or Chemical Engineering, Physics, Material Science or similar experience in Pharmaceutical/Biotechnology/Medical Combination Product industry

Nice to have:

  • Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
  • Proven track record of leading and executing cross-functional projects
  • Direct experience with the manufacturing process and material science of primary packaging components (glass/elastomers/polymers) for medical (aseptic) applications
  • An Operational Excellence approach to work, driving rapid results
  • A passion to deliver excellent work results
  • Broad understanding of Combination Product Design Controls and regulatory requirements on a global scale
  • Program and project management skills including: Strategic planning, execution and prioritization - integrating people/processes to achieve high performance, with detailed tracking of progress
  • Proactive risk assessment, management and mitigation
  • Change management
  • ability to lead and thrive in ambiguous environment
  • Consistent track record of success in operationalizing and executing critical initiatives
  • Emotional Intelligence skills including: Executive presence across functions and different levels of leadership
  • Influencing, understanding & addressing team dynamics
  • Navigating within a matrix environment
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

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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