Engineer I - Manufacturing Support

About the role

Amgen is hiring an Engineer I to support manufacturing processes at its Thousand Oaks Pilot Plant. The role covers operational support, troubleshooting and optimization of assigned equipment, and the design and implementation of new equipment such as stainless and single-use systems.

Key responsibilities

• Provide operational support, troubleshooting and optimization for assigned equipment, and advise on the design and implementation of new equipment (stainless and single-use systems)
• Support system reliability and operational optimization, identify performance risks such as single points of failure or obsolescence, and lead improvement efforts including cycle time, efficiency and yield gains
• Support technical investigations, root cause analysis and equipment troubleshooting, and analyze data using methods such as Statistical Process Control, Six Sigma and predictive maintenance
• Assist with new product and technology introductions, including engineering assessments, equipment modifications and engineering runs
• Collect, organize, analyze and present results for small-scale operational issues and engineering projects, and provide day-to-day onsite technical support
• Apply process engineering principles to the design, specification, installation, startup and validation of process equipment and systems
• Perform engineering studies and assessments, translate user and process requirements into engineering documentation, and communicate with supervisors and cross-functional teams
• Follow environmental health and safety rules and regulations

Required profile

• One of: Master's degree with 2 years of engineering experience, Bachelor's degree with 4 years, Associate's degree with 6 years, or high school diploma/GED with 8 years of engineering experience
• Preferred: Bachelor's degree in Chemical, Mechanical or Bioengineering
• Preferred: direct experience in regulated environments (FDA, cGMP, OSHA, EPA) and hands-on experience with complex manufacturing equipment, including cleaning, centrifuges, chromatography and filtration systems
• Preferred: experience in bulk biopharmaceutical production design, procurement, construction, startup and validation
• Ability to work 24/7 operations, including weekend shifts, after-hours coverage and on-call rotation

Required skills

• Foundational knowledge of Maximo or an equivalent asset management system
• Solid understanding of cGMP procedures and engineering practices in pharmaceutical/biotech production
• Experience with corrective and preventative actions and commissioning practices
• Technical writing, communication and presentation skills, and mentorship experience

What we offer

• Health, dental and vision coverage, life and disability insurance, and a retirement and savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives and flexible time-off plans
• Flexible work models where possible