Principal Quality Engineer - Commercial Quality

Tampa, FL, US
Sep 13, 2020
Required Education
High School or equivalent
Position Type
Full time

The Principal Quality Engineer - Commercial Quality is accountable for providing quality oversight of final product activities, ensuring that Quality Systems identified for commercial sustainment and life cycle management of commercially available final product, including devices and combination products, are appropriate and compliant. Manages high complexity programs with greater risk to the business including those which are novel or new to Amgen, electromechanical, and/or internally developed. Responsible to represent FPTQ Commercial in external engagements. Provides oversight of proper quality resource balancing on project(s) as required, ensuring FPTQ resources are proactively managed.

Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the commercial lifecycle, including content from suppliers and partners. Participates in ongoing evaluation of commercial final product requirements, in particular for specialized products. Approve device components and final product or the device constituent of a combination product specification as part of commercial program. Establishes and maintains the quality requirements for commercial process transfer. Participate in technical aspects of problem-solving, complaints, and other investigations for commercial products. Maintenance of Traceability Matrix and final product quality play. Key participant at design reviews. Quality approver of Design History File. Ensures that all Quality Requirements have been met and DHF is ready for GMP inspections, Inspection Readiness Activities, and Partner Audits. Obtains, reviews, and confirms readiness of documentation for inspections. Ensures control strategies have been established, implemented, and maintained throughout the commercial lifecycle. Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ Commercial Quality as needed.

Accountable for maintaining process for Level 2 Management Review.

Supports commercial program-related quality agreements.

Participates in generation of Quality agreements with third parties.

This position reports to the Director Commercial Quality, FPTQ. Is Advisor to Development Quality Lead in FPTQ; Advisor to Core Technologies Quality Lead and

Liaison with Site Quality and Advisor to Medical Information regarding instructional material interfaces with end user. Aligns with Attribute Sciences PD on analytical methods; Advises Marketing on quality aspects of training and demo systems; is Advisor to Product Complaints; Advisor to PQL/GOL/GPO and Advisor to CPTL/DPTL/STL/DTL.

Key Responsibilities
  • Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for Final Product Technologies activities.
  • Attend commercial program meetings as required as part of program working teams.
  • Work cross-functionally with individuals and project teams to ensure success of commercial project efforts.
  • Provide guidance on documentation structures created during lifecycle management activities.
  • Responsible for identifying proper GMP documentation strategies and repositories required to ensure compliance with applicable regulations and Amgen Procedures.
  • Provide input to change controls for projects, and review and approve relevant Design Control documentation.
  • Maintain Traceability Matrix and provide review and approval for subordinate project plans and associated projects and contribute to applicable Design Control Phase Design Reviews.
  • Provide Quality oversight of Design Characterization, Verification and Validation activities as required through change control and/or CAPA for life cycle management of commercial programs.
  • Ensure adherence to all relevant commercial final product regulations and standards.
  • Represent and participate in onsite supplier due diligence visits, as needed, in support of supplier investigations and qualification activities.
  • Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs.
  • Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
  • Projects may include secondary packaging, 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 related to life cycle management of commercial programs.
  • Participate in deviation, CAPA, and Complaint investigations for commercial programs.
  • Participate in audits and inspections, well-prepared including all relevant details supported by evidence.
  • Collaborate to develop complete formal written responses.

Basic Qualifications:
  • Doctorate degree and 2 years of Quality experience
  • OR
  • Master's degree and 6 years of Quality experience
  • OR
  • Bachelor's degree and 8 years of Quality experience
  • OR
  • Associate's degree and 10 years of Quality experience
  • OR
  • High school diploma / GED and 12 years of Quality] experience

Preferred Qualifications:
  • 7+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's degree in a Science field
  • Experienced in NPI/NPD
  • Ability to convey and defend quality perspective to various levels of stakeholders
  • Participate in full audit cycle
  • Ability to interface with Regulators, and articulate knowledge of their process
  • Ability to respond to RTQs both verbally and in writing
  • Ability to interpret technical standards, internal requirements, and regulations
  • Leadership skills and the ability to oversee multiple complex 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 leading and/or working as part of a combination product launch team
  • Able to successfully manage workload to timelines
  • Ability to effectively negotiate a position after taking feedback from multiple sources
  • Supervisory skills and/or demonstrated ability to lead without direct authority
  • 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)
  • Ability to travel +/- 20% of time to domestic and international Amgen sites

  • 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 design controls
  • Strong knowledge of quality engineering and device engineering
  • 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
  • Lead and motivate a team
  • Ability to drive continuous improvements
  • Ability to Influence
  • Command / seen as owner of their program
  • Excellent communication to all levels of the organization
  • Supervisory skills
  • Able to manage resources
  • Able to apply strategic and critical thinking
  • Able to perform with a Global mindset
  • Able to identify solutions with ambiguity
  • Ability to work independently with minimal supervision
  • Works on, and anticipates, abstract and complex problems
  • requiring evaluation of intangible variables
  • Exercises appropriate judgment in urgent and non-routine situations.
  • Experience supporting commercial products
  • Experience with biologic products

  • Provides Quality oversight to final product commercial activities and deliverables (A)
  • Quality approval of project related documents (D)
  • Quality approver and/or author for Quality Plan (D)
  • Advises PDT and/or technical team in collaboration with PQL on level of risk for development activities (A)

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.

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.