Sr. Quality Engineer - Final Product Technologies Quality, CORE
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Jun 8, 2019
View more
- Discipline
- Engineering, Marketing, Product Development/Management
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Key Responsibilities:
- Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for Final Product Technologies activities as they relate to Core Technologies (which include Physical Test and Inspection Methods, in-silico modeling, and Core Systems) during all phases of product and process development.
- 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. Advises as required during supplier qualification or onboarding and participate during method transfer from third-parties to Amgen sites.
- Provides Quality oversight of Method Characterization and Qualification/Validation/Transfer activities.
- Contribute to content and review of regulatory submissions and RTQs, support technical/design review, audits, and inspections for associated projects
- Scope of work may include physical test and inspection methods as well as Core Technologies covering a wide range of products, which includes but is not limited to vials, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. Work 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 final product or system.
- Responsible for ensuring program alignment and proper linkages when considering Core Technologies development, transfer, and remediation activities as required.
Basic Qualifications:
Doctorate degree
OR
Master's Degree and 3 years of Manufacturing, Quality or Engineering experience
OR
Bachelor's Degree and 5 years of Manufacturing, Quality or Engineering experience
OR
Associate's degree and 10 years of Manufacturing, Quality or Engineering experience
OR
High school diploma/GED and 12 years of Manufacturing, Quality or Engineering experience.
Preferred Qualifications:
- American Society for Quality (ASQ) certification
- ASQ Certified Quality Engineer (CQE)
- 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
- Bachelor's Degree in a Science or Engineering Field
- Ability to oversee multiple medium complexity 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 working as part of a combination product launch team
- Able to successfully 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)
- Execution of technical standards, internal requirements, and regulations
- Comfortable with both drug and device terminology
- Ability to travel +/- 25-30% of time to domestic and international Amgen sites, partners, or vendors
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.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert