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
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
o Doctorate Degree
o Master's Degree and 3 years of Manufacturing and Operations experience
o Bachelors degree and 5 years of Manufacturing and Operations experience
o Associate's Degree and 10 years of Manufacturing and Operations experience
High school diploma / GED and 12 years of Manufacturing and Operations experience
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.
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 UsIf 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.