Sr. Packaging Engineer
Amgen
- Thousand Oaks, CA
- $114,962-139,704 per year
- Permanent
- Full-time
- Possible management of junior level engineers and contingent workers
- Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products
- Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP
- Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
- Crafting specifications along with implementation through technical change records
- Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
- Assist in trouble shooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)
- Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
- Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities
- Represent CPO and Manufacturing Sciences and Technology (MSAT) as Final Product Technical Lead
- Support Pre-Approval Inspections, Audits, and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed
- Bachelor’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
- 7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry
- Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.
- Knowledge of primary and secondary packaging systems and material science is critical to the position
- Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment
- Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Independent problem solver with demonstrated skills working in teams or leading project teams
- 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