Amgen Sr Quality Engineer (US Remote) in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Sr Quality Engineer
What you will do
Let’s do this. Let’s change the world. In this vital role you will be 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.
Ensures that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Manages low to moderate complexity programs with minimal direction. Provides input on accurate quality resource balancing on project(s) as required.
Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the design and development lifecycle, including content from suppliers and partners. Participates in development of final product requirements. Approves device components and final product or the device constituent of a combination product specification as part of development program.
Establishes the quality requirements for development process to transfer design. Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design control investigations on an as needed basis.
Participates in creation, updating, and maintenance of Traceability Matrix. Develops and maintains final product quality plan. Quality approval at all key design phases (i.e., verification, validation, development, and launch readiness) and key participant at design reviews. Quality approver of the Design History File.
Ensures that all Quality Requirements have been met and DHF is ready for Prior Approval Inspections (PAIs), Inspection Readiness Activites, and Partner Audits. Responsible to assemble documentation needed for inspections. Ensures control strategies have been established, implemented, and maintained throughout the design and development lifecycle.
Supports development of program-related quality agreements. Participates in generation of development agreements with third parties.
This position collaborates with the Director Development Quality, FPTQ and is Advisor to Innovation Quality Lead in FPTQ, Advisor to Commercial Quality Lead and Liaison with FPTQ Commercial. Advisor to Medical Information regarding instructional material collaborates with end user, aligns with Attribute Sciences PD on analytical methods
Provides guidance to 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.
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 multi-functionally with individuals and project teams to ensure success of development project efforts. Provide mentorship on documentation structures crafted during development activities. Responsible for identifying accurate GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable laws and Amgen Procedures.
Provide guidance 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 alignment 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 accurate 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality Engineering professional we seek is a candidate with these qualifications.
Basic Qualifications :
Doctorate degree OR
Master’s degree and 3 years of Quality experience OR
Bachelor’s degree and 5 years of Quality 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 supervise multiple medium complexity projects simultaneously
Solid understanding 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 optimally 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) Delivery 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
Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
Combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls
Knowledge of quality engineering and device engineering
Proven 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 multi-functional teams and in a highly matrixed team environment
Constructively progress to outcomes despite uncertainty or ambiguity
Motivate change, efficiency, and strong multi-functional relationships
Excellent verbal and written communication
Lead and motivate a team
Ability to drive continuous improvements Technical writing
Situational analysis and reporting
Process improvement focus(CI / Lean)
Provides Quality guidance to final product development activities and deliverables (A)
Quality approval of project related design control 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 phase specific development activities (A)
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.