Validation Engineer

Amgen UK

Computer systems validations (csv)
Gamp 5
21 cfr part 11 compliance
You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing

Job Summary

  • You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing.
  • This vital role ensures Amgen systems remain compliant with industry standards and comply with all regulatory requirements.
  • Our award-winning culture is collaborative, innovative, and science based.

Matching Summary

You will play a pivotal role in ensuring compliance across the Process Development and Manufacturing.

Skills & Requirements

Must-have

  • Computer Systems Validations (CSV)
  • GAMP 5
  • 21 CFR Part 11 Compliance
  • Veeva (all modules)
  • ALM testing and ALM software

Nice-to-have

  • work with global, virtual teams
  • excellent analytical and troubleshooting skills
  • strong presentation and public speaking skills
  • FDA Audit experience

Key Requirements

  • Master’s degree with 8 - 12 years of experience
  • Bachelor’s degree with 10 - 14 years of experience
  • minimum of 3 to 5 years in pharmaceutical industry
  • Experience with regulatory agencies – FDA, EMEA, CFDA

Work Rights

Not specified

Tailored Resume

Cover Letter