Associate Manufacturing
Amgen
- Thousand Oaks, CA
- $67,083-84,094 per year
- Permanent
- Full-time
- Perform and monitor critical processes
- Execute routine validation protocols
- Comply with GMP's
- Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
- Initiate and own quality records, such as CAPA, and CAPA-EV.
- Identify and recommend improvements related to routine functions and implement after approval
- Basic troubleshooting
- Recognize and accurately report problems
- Direct operators on critical processes
- Assist in the review of documentation for assigned functions (e.g. routine area audits, batch records)
- Performing activities that include periods of rigorous, repetitive work
- Working around high-pressure systems and occasionally work around heavy equipment
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
- May train staff to perform hands-on tasks
- May act as safety representative
- May participate on cross-functional teams and represent manufacturing
- Available to work on site
- Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
- Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
- Bachelor's degree in Science or Engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
- Knowledge of Single-use-Systems
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Demonstrated technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on production equipment
- Experience with Delta V
- Experience with lab equipment/testing
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible