Sr. Packaging Engineer
AmgenAbout the role
Career Category
EngineeringJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr. Packaging Engineer
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will report into the Packaging Engineering group under Combination Product Operations (CPO) and is located in Thousand Oaks, CA. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials used in healthcare packaging is key to this role. Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. This role may have some junior level management potential and the successful candidate will also apply excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a dynamic environment.
Responsibilities:
- 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
Win
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Master’s degree and 2 years of Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
Bachelor’s degree and 4 years of Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
Or
Associate’s degree and 8 years of Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
Or
High school diploma / GED and 10 years of Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
Preferred Qualifications:
- 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 Practic
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