Senior Packaging Engineer - NB50237671 - Thousand Oaks, CA.

Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.This position reports into the Device and Packaging Engineering group under Global Drug Product and Device Development in Thousand Oaks. The Senior Packaging Engineer position falls within 3 different categories in Device and Packaging Engineering; Pre-Commercial, Commercial and Platform Engineering. This position will be required to apply advance and diverse engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and processes, manufacturing fill/finish equipment and processes, material science and quality system is essential to the position. The position requires excellent organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. This position is responsible and accountable for the following: 1) Evaluation, recommendation and selection of primary and secondary packaging materials for both large and small molecules product.2) Write tests protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials.3) Write Technical Specifications and Bill of Materials4) Representing D&PE in Drug Product and Global Operation Teams5) Technology transfer from clinical to commercial or from site to site for both packaging components and equipment processes6) Ensures that line trials and packaging validation is conducted prior to introduction of any new or change in components/processes7) Ensures cGMP and regulatory compliance are met8) Ensures that change control procedures are followed working with QA and Regulatory to implement changes9) Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc) as needed10) Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.11) Assess, develops, and implements solutions for complex problems relating to packaging or packaging systems.12) Oversees project implementation of critical new package platforms.Basic: BA in Packaging, Engineering or Life Sciences5 to 8 years of packaging/engineering experience Preferred: MS in Packaging, Engineering or Life Sciences7 to 10 of packaging/engineering experience with 4+ years within the Pharma/Bio industryDemonstrated Competencies/Skills:1) Independent thinker with demonstrated skills working in teams or leading project teams2) Strong Interpersonal and communication skills Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen Inc Location: Thousand Oaks, CA 91319 Job Category: Other Reference Code: 50237671