AddressHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
The Principal Quality Engineer – Development Quality
Live
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 associated with Final Product Technologies activities.
Responsibilities:
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.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an engineer with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Quality experience
Or
Master’s degree and 4 years of Quality experience
Or
Bachelor’s degree and 6 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
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
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.
