Senior Quality Engineer

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Job description

HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live
What you will do
Lets do this! Lets change the world!
Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material
characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies and/or to sites. Ensures successful physical
method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.
Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier.
Disposition of reports associated with FP platforms and method stewardship and ensure
robust FP method stewardship program (GMP methods and verification methods used to support filings).
Disposition of reports associated with FP modeling and material characterization to support
FP development and commercial operations. Identifies compliance risks and provides mitigation strategies to support PAI and inspection success.
Maintains strong relationship with other Quality functions to ensure feedback loops on existing methods
Provides quality oversight of the development, maintenance, transfer and validation of physical methods including sample selection
Provides quality advice to maintain and improve container, device, and packaging/shipping platforms
Provides quality advice to regulatory on submission strategies associated with platforms, physical methods, and modeling
Provides oversight of FPT deliverables associated with established FP platforms, physical
methods, FP modeling, and material sciences
Provide quality expertise and technical knowledge to Final Product Key internal Initiative (KEI)
Co-develop training materials for method transfers and stability method transfers with FPT
Core Technologies

• Co-develop training materials for stability method transfers with FPT Core Technologies
• Ensures activities are in line with budget and support evidence-based resource needs
• Provides Quality oversight to final product core technologies activities and deliverables (A)
• Quality approval of protocols and technical reports for method development (D)
• Provides advice to inform Quality Plan (A)
• Provides advice and expertise to inform development of technical training materials for method transfer (A)
• Oversight of protocols and requirements to outsource testing to labs (A)
• Approved method development, validation, and transfer reports
• Robust FP change controls, CAPAs, and NCs
• Successful FP method stewardship deliverables
• Method training materials
• Reports to Director, Final Product Technologies Quality
• Key advisor to Core Technologies Lead in Final Product Technology
• Advisor to Innovation and Development Leads in FTPQ
• Advisor to site quality organizations
• Advisor to Product Quality Leaders (PQLs)
• Consult with and/or provide advice to Regulatory to inform submissions
• Align with Attribute Sciences where similar networks or governances are established
• Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliers

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality experience OR
• Masters degree and 6 years of quality experience OR
• Bachelors degree and 8 years of quality experience OR
• Associates degree and 10 years of quality experience OR
• High school diploma / GED and 12 years of quality experience AND 2 years of managerial experience directly management of projects, programs or directing the allocation of resources

Requirements:

• Deep and broad understanding of quality processes including change control, risk assessment and management, etc.
• Familiarity with the characterization and modeling techniques being employed in FP development
• Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
• l Strong problem solving, trouble shooting, and analytical skills
• Advanced technical writing skills
• Constructively progress to outcomes despite uncertainty or ambiguity
• Motivate change, efficiency, and strong cross-functional relationships
• Excellent verbal and written communication
• Ability to effectively negotiate and Influence at all levels of the organization
• Ability to drive continuous improvements

Preferred Requirements:

• 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelors Degree in a Science Field
• Experience in developing physical methods for combination products
• Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP
• Leadership skills and the ability to oversee multiple projects simultaneously
• Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025
• Ability to discern user requirements for input to method development
• Able to successfully manage workload to timelines
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high quality results
• 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/expectation Ability to travel +/- 20% of time to domestic and international Amgen site
• Experience with Quality Processes and systems such as Trackwise
• Experience with quality oversight of device components
• History of presenting during inspections and audits
• Able to facilitate and influence senior stakeholders and partners
• Able to successfully prioritize workload and meet timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
• Deep and broad understanding of quality processes including change control, risk assessment and management,
• Strong problem solving, trouble shooting, and analytical skills
• Advanced technical writing skills
• Constructively progress to outcomes despite uncertainty or ambiguity
• Inspire change, efficiency, and strong cross-functional relationships
• Excellent verbal and written communication
• Ability to drive continuous improvements

Thrive
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 maximize 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com

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...... click apply for full job details