Amgen UK is seeking a Downstream System Owner to support manufacturing activities associated with cGMP equipment and facilities at their Thousand Oaks location. The ideal candidate will have significant experience in engineering and operations within regulated environments, with a focus on quality and safety in biotech production processes
Job Summary
The role supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks while driving safety and quality compliance.
Engineers will provide direct technical support for equipment performance, reliability, and lead aspects of the operation including capital projects.
Amgen offers a comprehensive benefits package including retirement plans, health coverage, and flexible work models to support professional growth.
Matching Summary
Match Score: 85
Amgen UK is seeking a Downstream System Owner to support manufacturing activities associated with cGMP equipment and facilities at their Thousand Oaks location. The ideal candidate will have significant experience in engineering and operations within regulated environments, with a focus on quality and safety in biotech production processes.
Salary
Base: $88,281.00 - $119,439.00 USD annually; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, and retirement savings plan
Skills & Requirements
Must-have
cGMP procedures and engineering practices
downstream purification equipment knowledge
validation protocol development and execution
risk-based verification on GMP process equipment
experience in regulated pharmaceutical environments
Nice-to-have
Lean Transformation and Six Sigma methodologies
Delta V, Rockwell, and Plant Information Systems
Strong communication and technical writing skills
Mentoring project teams and engineers
Experience with combination product quality systems
Key Requirements
Master's degree OR Bachelor's degree with 2 years experience
7+ years relevant work experience preferred
Direct experience with FDA, OSHA, EPA regulated environments
Knowledge of cell culture, fermentation, and purification processes