Validation Engineer

Amgen

Not specified; not specified; competitive total re...
3 to 5 years pharmaceutical industry experience
Computer systems validations csv expertise
Gamp 5 regulatory compliance knowledge
This role ensures Amgen systems remain compliant with industry standards and all regulatory requirements through computerized system validations

Job Summary

  • This role ensures Amgen systems remain compliant with industry standards and all regulatory requirements through computerized system validations.
  • The team operates within a collaborative, innovative, and science-based culture focused on serving patients living with serious illnesses.
  • Amgen offers competitive Total Rewards Plans aligned with local industry standards to support professional and personal growth.

Matching Summary

This role ensures Amgen systems remain compliant with industry standards and all regulatory requirements through computerized system validations.

Salary

Not specified; Not specified; Competitive Total Rewards Plans aligned with local industry standards

Skills & Requirements

Must-have

  • 3 to 5 years pharmaceutical industry experience
  • Computer Systems Validations CSV expertise
  • GAMP 5 regulatory compliance knowledge
  • 21 CFR Part 11 and Part 210 211 rules
  • Veeva suite modules CDocs QMS RIM DocuSign
  • ALM testing software proficiency
  • IQ OQ script development skills

Nice-to-have

  • FDA audit experience with regulatory agencies
  • Smartsheets Salesforce Tableau tool usage
  • Strong transformation and change management
  • Experience working with global virtual teams
  • Excellent presentation and public speaking skills

Key Requirements

  • Master's degree with 8-12 years experience OR Bachelor's with 10-14 years
  • Minimum 3 to 5 years in pharmaceutical industry validation
  • Fluent knowledge of FDA EMEA CFDA regulations
  • Expertise in SDLC methodologies and testing best practices

Work Rights

Not specified

Tailored Resume

Cover Letter