Sr. Validation Engineer

Design Group

7+ years validation experience
Gmp regulated environment knowledge
Fat sat iq oq execution
This role involves supporting capital project CQV delivery and embedding compliance into early design phases for pharmaceutical and medical device clients

Job Summary

  • This role involves supporting capital project CQV delivery and embedding compliance into early design phases for pharmaceutical and medical device clients.
  • Candidates will work within a Regulatory Compliance Practice to develop and execute validation documents including User Requirement Specifications and risk assessments.
  • The position offers opportunities for growth through mentorship programs and professional development resources within a rapidly growing business unit.

Matching Summary

This role involves supporting capital project CQV delivery and embedding compliance into early design phases for pharmaceutical and medical device clients.

Skills & Requirements

Must-have

  • 7+ years validation experience
  • GMP regulated environment knowledge
  • FAT SAT IQ OQ execution
  • User Requirement Specifications authoring
  • Risk-based validation approaches

Nice-to-have

  • Digital Validation Tools proficiency
  • Project lifecycle concept to startup
  • Strong technical writing skills
  • Client relationship management
  • Travel flexibility for projects

Key Requirements

  • Minimum 7+ years demonstrated experience
  • Bachelor's degree in Engineering
  • Experience with automation and packaging systems
  • Knowledge of CFR Parts 210, 211, 11
  • Ability to travel as necessary

Work Rights

Not specified

Tailored Resume

Cover Letter