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Sr. Validation Engineer

Employer
Amgen
Location
West Greenwich, RI
Start date
Jun 30, 2021

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Job Details

The Senior Validation Engineer position is within the Product Lifecycle Management

organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing

plant that produces multiple commercial and clinical products. The team is responsible for new

product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Islands Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARIs product portfolio.

Shift: Monday Friday Admin Day Shift

Responsibilities:

o Develop Validation plans, execute validation Performance Qualifications (PQ)

o Responsible for the following activities:

  • Cleaning and steaming validation strategy for NPI and / or equipment modifications
  • Clean utility validation for new or modified systems
  • Validation of new MFG benchtop equipment
  • Autoclave validation strategy and improvements

o Drive continuous improvements of Validation programs and processes

o Maintain the site cleaning acceptance criteria:

  • Calculate the maximum allowable carryover (MAC)
  • Strong proficiency with Excel
  • Understanding of the calculations and their scientific basis

o Oversee equipment validation, verification, equipment release and cleaning monitoring programs:

  • Execution support for these activities
  • Ownership of program SOPs

o Point of contact for validation impact during project planning and development

o Assist in developing and delivering training materials to manufacturing staff to support validation activities

o Validation planning:

  • Knowledge of steaming and cleaning design concepts and the ability to determine worst case cleaning and steaming paths for various equipment types
  • Proficiency in interpreting automation and engineering design documents

Basic Qualifications

o Doctorate Degree

OR

o Master's Degree and 3 years of Manufacturing and Operations experience

OR

o Bachelors degree and 5 years of Manufacturing and Operations experience

OR

o Associate's Degree and 10 years of Manufacturing and Operations experience

High school diploma / GED and 12 years of Manufacturing and Operations experience

Preferred Qualifications

o Manufacturing experience in both upstream and downstream operations.

o Cleaning / Steaming Validation experience

o Strong project management skills.

o Technical leadership experience.

o Strong understanding of manufacturing equipment and processes.

o CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.

o Strong analytical and experimental design skills.

o Excellent verbal and written communication skills.

#Operation21

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.


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.

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.

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Company info
Website
Telephone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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