Sr. Quality Engineer - Final Product Technologies Quality, CORE

The Sr. Quality Engineer - Core Technologies Quality is accountable for advice and oversight regarding technical aspects of test and inspection method development, qualification/validation, and transfer for combination and non-combination products. This role will be a single Quality point of contact for test and inspection method related issues during development of combination and non-combination products. In addition, the Sr. QE will support development of in-silico modeling and implementation of Core Technologies alongside Final Product Technologies personnel.

Key Responsibilities:

• Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for Final Product Technologies activities as they relate to Core Technologies (which include Physical Test and Inspection Methods, in-silico modeling, and Core Systems) during all phases of product and process development.
• Attend program meetings as required as part of extended program teams. Works cross-functionally with individuals and project or extended teams to ensure success of project efforts. Provide guidance on documentation structures created for Core Technologies. Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation and data management strategies and repositories required to ensure compliance with applicable regulations and Amgen Procedures.
• Supports technical and design review activities as an advisor or SME. Advises as required during supplier qualification or onboarding and participate during method transfer from third-parties to Amgen sites.
• Provides Quality oversight of Method Characterization and Qualification/Validation/Transfer activities.
• Contribute to content and review of regulatory submissions and RTQs, support technical/design review, audits, and inspections for associated projects
• Scope of work may include physical test and inspection methods as well as Core Technologies covering a wide range of products, which includes but is not limited to vials, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. Work may include test or inspection method development/remediation for projects/programs as they relate secondary packaging, primary container, mechanical, electrical, thermal engineering, and/or software as part of the final product or system.
• Responsible for ensuring program alignment and proper linkages when considering Core Technologies development, transfer, and remediation activities as required.

Basic Qualifications:

Doctorate degree

OR

Master's Degree and 3 years of Manufacturing, Quality or Engineering experience

OR

Bachelor's Degree and 5 years of Manufacturing, Quality or Engineering experience

OR

Associate's degree and 10 years of Manufacturing, Quality or Engineering experience

OR

High school diploma/GED and 12 years of Manufacturing, Quality or Engineering experience.

Preferred Qualifications:

• American Society for Quality (ASQ) certification
• ASQ Certified Quality Engineer (CQE)
• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
• Bachelor's Degree in a Science or Engineering Field
• Ability to oversee multiple medium complexity projects simultaneously
• Working knowledge of quality engineering and/or mechanical engineering
• Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 11, 820, 210 and 211)
• Prior experience working as part of a combination product launch team
• Able to successfully manage workload to timelines
• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience driving decision-making by using DAI principles
• Understanding of industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Execution of technical standards, internal requirements, and regulations
• Comfortable with both drug and device terminology
• Ability to travel +/- 25-30% of time to domestic and international Amgen sites, partners, or vendors

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 people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 Us

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.