Senior Quality Engineer

Lets do this. Lets change the world. In this vital role you willhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.



Senior Quality Engineer



What you will do
Lets do this. Lets change the world. In this vital role you be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE 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.




Responsibilities:

Co-develop training materials for stability method transfers with CPO

Ensures activities are in line with budget and support evidence-based resource needs

Provides quality oversight of the development, maintenance, transfer and validation of physical methods including sample selection

Provides Quality guidance to CPO activities and results

Quality approval of protocols and technical reports for method development

Provides advice to inform Quality Plan

Provides advice and expertise to inform development of technical training materials for method transfer

Oversight of protocols and requirements to outsource testing to labs

Review/Approve method development, validation, and transfer reports

Robust change controls, CAPAs, and NCs

Successful CPO method stewardship work

Method training materials

Reports to manager CPOQ Core in Thousand Oaks.

Key advisor to Core Technologies Lead

Advisor to Innovation and Development Leads

Advisor to site quality organizations

Advisor to Product Quality Leaders (PQLs)

Collaborate 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

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 is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree OR

Masters degree and 4 to 6 years of Quality experience OR

Bachelors degree and 6 to 8 years of Quality experience OR

Diploma and 10 to 12 years of Quality experience

Preferred Qualifications:

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 Combination product development

Ability to work effectively in global multi-functional teams and in a highly matrixed team environment

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 multi-functional relationships

Ability to drive continuous improvements

Quality and manufacturing experience in biotech or pharmaceutical industry

Bachelors Degree in a Science Field

Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP

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 negotiate a position after taking feedback from multiple sources

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 communicating during inspections and audits

Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution