Amgen

Sr Quality Engineer

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 21, 2019
Ref
R-76569
Required Education
High School or equivalent
Position Type
Full time
The Sr 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.

Key Responsibilities:
  • Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies 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. Responsible for identifying 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 final product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocls 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. Also 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 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). Responsible for ensuring 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.


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 E 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:
  • 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
  • Bachelor's Degree in a Science 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, 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 +/- 15-20% of time to domestic and international Amgen sites


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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.