Amgen Principal Quality Engineer - Development Quality in Cambridge, Massachusetts
The Principal Quality Engineer – Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products associated with Final Product Technologies activities.
Accountable for ensuring that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities.
Attend development program meetings as required as part of program working teams.
Work cross-functionally with individuals and project teams to ensure success of development project efforts.
Provide guidance on documentation structures created during development activities.
Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and Amgen Procedures.
Provide input to the Design and Development Plans for projects, and review and approve relevant combination product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
Actively participate and contribute to applicable Design Control Phase Design Reviews.
Provide Quality oversight of Design Characterization and Verification and Validation activities.
Ensure adherence to all relevant regulations and standards based on the type of device under development.
Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses. Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence and for associated projects.
Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s).
Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.
Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ Development Quality as needed.
Doctorate degree and 2 years of Quality experience
Master’s degree and 6 years of Quality experience
Bachelor’s degree and 8 years of Quality experience
Associate’s degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
7+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor's degree in a Science field
Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
Deep combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter into design controls
Strong knowledge of quality engineering and device engineering
Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
Strong problem solving, trouble shooting, and analytical skills
Advanced technical writing skills
Able to balance complexity between innovation and regulation
Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
Constructively progress to outcomes despite uncertainty or ambiguity
Drive change, efficiency, and strong cross-functional relationships
Excellent verbal and written communication
Ability to drive continuous improvements
Ability to Influence and demonstrate strong command / seen as owner of their program
Excellent communication to all levels of the organization
Supervisory skills and/or demonstrated ability to lead without direct authority
Experience driving decision making by using DAI principles
Able to manage resources
Able to apply strategic and critical thinking
Able to perform with a Global mindset
Ability to travel +/- 15-20% of time to domestic and international Amgen sites
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.
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