Senior Validation Engineer

West Greenwich, RI, US
Aug 28, 2020
Required Education
High School or equivalent
Position Type
Full time
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 in AR5 and managing the life cycle of ARI's product portfolio. This role will focus on manufacturing validation activities at ARI including but not limited to cleaning validation, SIP/Autoclave validation and analytical equipment validation.

Scope of Responsibility
  • Develop the manufacturing validation strategy. Compare/contrast current vs future state based on information provided in detailed design meetings, change controls, etc. in order to assess changes for impact to validation.
  • Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case.
  • Develop area/project specific Validation Plans. Prepare, execute, and finalize validation/commissioning protocols and reports.
  • Develop, maintain, and communicate project schedules. Coordinate the individual tasks among cross functional teams to prepare for and execute validation.
  • Represent Manufacturing Validation in project team meetings. Convey impact on coworkers' areas of responsibility.
  • Ensure that all test procedures are in line with current corporate and governmental regulations.
  • Manage execution of tasks for contractors supporting your work.
  • Assist in deviation and exception resolution and root cause analysis.
  • Participate in audits/inspections to defend validation strategy.
  • Drive continuous improvement of the commissioning/qualification process by working with a cross functional team.

Basic Qualifications:
  • Doctorate Degree
  • OR
  • Master's Degree & 3 years of Manufacturing & Operations experience
  • OR
  • Bachelor's Degree & 5 years of Manufacturing & Operations experience
  • OR
  • Associate's degree & 10 years of Manufacturing & Operations experience
  • OR
  • High school diploma/GED & 12 years of Manufacturing & Operations experience

Preferred Qualifications:
  • Manufacturing experience in both upstream and downstream operations.
  • Strong understanding of manufacturing equipment and processes.
  • Analytical and detail oriented.
  • Excellent verbal and written communication skills.
  • Project management/time management skills.
  • Demonstrated leadership skills.
  • Ability to understand and apply key engineering principals and concepts.
  • Ability to manage multiple concurrent work streams and flexibility to shift priorities to meet business needs.
  • Proficiency with analytical tools, such as Excel and Pi.

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

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.