The Sr Quality Engineer - Core Technologies Quality is accountable for providing quality oversight of Test and Inspection Method (TIM) Development, Qualification, Validation and Transfer, ensuring that documentation for TIM is robust, consistent, and compliant for Component and Final Product testing. This role is also accountable for providing quality oversight of Core Systems Development (e.g. HLEE, IS4PD, EDL), Implementation and Maintenance ensuring that documentation for Core Systems is robust, consistent, and compliant. Additionally, this role is accountable for providing quality oversight of in-silico modeling activities and documentation and provides input on proper quality resource balancing on project(s) as required.
This position reports to the Sr. Manager, Core Technologies Quality FPTQ and is an advisor to Development and Commercial Quality Leads, as well as the Complaint Lead. The Senior Quality Engineer is a liaison with FPTQ Early Engagement, Development, Commercial, Complaints and Site Quality; aligns with Chemical/Analytical Test Methods Lead on strategy and documentation. This position is also an advisor to Product Complaints, advisor/liaison to FPT Core Technologies for all Core Technologies and Systems, liaison with Quality Engineering and other Quality functions as required.
+ Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for Final Product Technologies activities related to Core Technologies (which include Physical Methods, in-silico modeling, and Core Systems).
+ Attend program meetings as required as part of extended program teams.
+ Works cross-functionally with individuals and project or extended teams to ensure success of project efforts.
+ Provide guidance on documentation structures created for Core Technologies.
+ Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation and data management strategies and repositories required to ensure compliance with applicable regulations and Amgen Procedures.
+ Supports technical and design review activities as an advisor or SME.
+ Advise as required during supplier qualification or onboarding and participate during method transfer from third-parties to Amgen sites.
+ Provide Quality oversight of Method Characterization and Qualification/Validation/Transfer activities.
+ Ensure adherence to all relevant regulations and standards.
+ Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects.
+ Participates in projects which may include methods and Core Technologies covering 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.
+ Participates in development projects which may include test or inspection method development/remediation for projects/programs as they relate secondary packaging, primary container, mechanical, electrical, thermal engineering, and/or software as part of the system(s).
+ Responsible for ensuring program alignment and proper linkages when considering Core Technologies development and remediation activities.
+ Participate in deviation, CAPA, Level 2 Management Review, Annual Product Review & Complaint investigations as required.
+ Ability to travel +/- 30% of time to domestic and international Amgen sites
Master's degree and 3 years of Quality experience
Bachelor's degree and 5 years of Quality experience
Associate's degree and 10 years of Quality experience
High school diploma/GED and 12 years of Quality experience.
+ 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
+ Bachelor's Degree in a Science Field
+ Experienced in NPI/NPD or Sustaining Operations regarding drug product, devices, and/or combination products.
+ 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, 11, 820, 210 and 211)
+ Prior experience leading and/or working as part of a combination product launch team
+ Prior experience serving as an independent reviewer/auditor or assistant
+ Able to successfully manage workload to timelines
+ Ability to effectively negotiate 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)
+ ASQ Certification Preferred, ASQ CQE Highly Preferred
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.
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_
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.