Amgen - Thousand Oaks, CA

posted 13 days ago

Full-time - Senior
Remote - Thousand Oaks, CA
Chemical Manufacturing

About the position

The Principal Manufacturing Systems Engineer at Amgen plays a crucial role in ensuring the success of drug product manufacturing. This position requires a deep understanding of engineering principles, particularly in process controls, automation, and instrumentation technologies. The engineer will be responsible for designing, developing, and implementing innovative solutions to enhance manufacturing processes, while also providing technical leadership and operational support.

Responsibilities

  • Provide technical leadership for day-to-day operational shift support for Drug Product manufacturing.
  • Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
  • Act as a Subject Matter Expert for Drug Product Filling lines, establishing relationships with OEMs and leading troubleshooting activities.
  • Drive continuous improvement in manufacturing processes in collaboration with plant engineering and maintenance teams.
  • Maintain user requirements, design specifications, and spare parts management for filling lines.
  • Support operations of associated plant utilities related to filling lines.
  • Ensure compliance with Amgen Enterprise Cyber Resiliency through quarterly OS patching of automation systems.
  • Communicate automation topics effectively in various workplace forums.
  • Support internal and external regulatory audits for assigned filling lines.
  • Lead and implement Continuous Improvement and Capital projects, developing scope, budget, and schedule.
  • Develop and maintain Engineering Specifications, documents, and Standard Operational Procedures (SOP).
  • Lead new product introductions or technology introductions in collaboration with multi-functional teams.

Requirements

  • Doctorate degree and 2 years of Engineering experience, or
  • Master's degree and 4 years of Engineering experience, or
  • Bachelor's degree and 6 years of Engineering experience, or
  • Associate degree and 10 years of Engineering experience, or
  • High school diploma / GED and 12 years of Engineering experience.

Nice-to-haves

  • Master's or Bachelor's Degree in Electrical Engineering or a related field.
  • Experience in the process automation field within the biopharmaceutical industry.
  • Experience with Drug Product unit operations such as Lyophilizer, Vial & Syringe Filler, Vial Washer, Capper, Depyrogenation oven & Tray Loader.
  • Experience leading teams to perform advanced troubleshooting activities.

Benefits

  • Comprehensive employee benefits package including medical, dental, and vision coverage.
  • Retirement and Savings Plan with generous company contributions.
  • Life and disability insurance.
  • Flexible spending accounts.
  • Discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements.
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