Sr. Packaging Engineer
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 devices.
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 required. Key Material knowledge requirements of the structural components and chemical properties of glass, polymers, adhesives, inks, varnishes and paper is required. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position.
This role requires entry level management, 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:
- 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 commercial activities.
- Doctorate degree OR
- Masters degree & 3 years of directly related experience OR
- Bachelors degree & 5 years of directly related experience
- MS in Materials Science, Mechanical Engineering, Chemical Engineering or packaging Engineering
- 7 or more years of packaging materials experience with 4+ years within the Pharma/Bio industry
- Leading teams
- Independent thinker with demonstrated skills working in teams or leading project teams
- Strong Interpersonal and communication skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Equal Opportunity Statement
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.
Join UsIf 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.