Amgen Sr Packaging Engineer in Thousand Oaks, California
This position reports into the Packaging Engineering group under Final Product Technologies in Amgen. The position will support global supply, new product introductions, partnerships/acquisitions and combination products.
This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes.
A strong knowledge of common materials utilized in pharmaceutical packaging is important in fulfilling this role. Key Material knowledge requirements of the structural components and chemical properties of glass, polymers, adhesives, inks, varnishes and paper is integral in the day to day oversight of this role. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position. This role will have some entry level management potential and the successful candidate will also utilize excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment.
This position is responsible and accountable for the following:
Management of entry level engineers and contingent workers.
Evaluation, recommendation and selection of new packaging materials for both large and small molecules product.
Assessing complex problems relating to materials, recommending and implementing solutions
Write test protocols, perform technical evaluations and submitting technical
assessment reports to justify the use of selected materials.
Write Technical Specifications
Representing Final Product Technologies as required
Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
-Establish priorities to ensure all projects are managed within expected due dates
Lead and present new packaging ideas, concepts and design ideas to the Product Development team.
Ensures cGMP and regulatory compliance are met
Ensures that change control procedures are followed working with QA and
Regulatory to implement changes
- Participants in Pre-Approval Inspections (PAI) and interact with regulatory
bodies (e.g., FDA, EMEA, etc) as needed
- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply
Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and
Doctorate degree and 2 years of Packaging Engineering experience
Master’s degree and 6 years of Packaging Engineering experience
Bachelor’s degree or and 8 years of Packaging Engineering experience
Associate’s degree and 10 years of Packaging Engineering experience
High school diploma / GED and 12 years of Packaging Engineering experience
Master’s degree in Materials Science, Mechanical Engineering, Chemical Engineering or Packaging Engineering
7+ years of packaging materials experience with 4+ years within the Pharma/Bio industry
Independent thinker with demonstrated skills working in teams or leading project teams
Strong Interpersonal and communication skills
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.