Lead Validation Eng

Par Health

Fully remote
10 years pharmaceutical validation experience
Gxp gamp5 part 11 data integrity knowledge
Ich q7 q9 q11 regulatory guidelines
The Lead Validation Engineer ensures product quality and site compliance with regulatory requirements by creating and executing primary qualification activities

Job Summary

  • The Lead Validation Engineer ensures product quality and site compliance with regulatory requirements by creating and executing primary qualification activities.
  • This role requires a minimum of 10 years of experience in reviewing and approving validation within a pharmaceutical manufacturing environment.
  • The position involves managing the data integrity program, including assessments and mitigations for both laboratories and manufacturing operations.

Matching Summary

The Lead Validation Engineer ensures product quality and site compliance with regulatory requirements by creating and executing primary qualification activities.

Skills & Requirements

Must-have

  • 10 years pharmaceutical validation experience
  • GxP GAMP5 Part 11 Data Integrity knowledge
  • ICH Q7 Q9 Q11 regulatory guidelines
  • Validation document review and approval
  • Risk assessment per ICH Q9
  • Cleaning validation protocol development

Nice-to-have

  • Six Sigma and Lean manufacturing tools
  • Thermometric studies instrumentation experience
  • Excellent written and oral communication
  • Ability to lead cross-functional teams
  • Audit support experience

Key Requirements

  • Bachelor's degree in science or engineering
  • Minimum 10 years validation experience
  • Knowledge of US and International regulations

Work Rights

Not specified

Tailored Resume

Cover Letter