Sr. Validation Engineer

Endogastricsolutions

Unknown
Process and cleaning validation
Fda and cgmp compliance
Statistical process control techniques
At Par Health, we believe great healthcare is built on getting the essentials right and fostering a culture of continuous improvement, accountability, and teamwork

Job Summary

  • At Par Health, we believe great healthcare is built on getting the essentials right and fostering a culture of continuous improvement, accountability, and teamwork.
  • This role involves managing multiple cross-functional validation projects from development through production release, supporting manufacturing, packaging, and quality control.
  • The position requires ensuring product quality through robust testing, process monitoring, and compliance with FDA, EU, and JP cGMP regulations.

Matching Summary

At Par Health, we believe great healthcare is built on getting the essentials right and fostering a culture of continuous improvement, accountability, and teamwork.

Skills & Requirements

Must-have

  • process and cleaning validation
  • FDA and cGMP compliance
  • statistical process control techniques
  • equipment and packaging line qualification
  • data integrity compliance
  • cross-functional project coordination

Nice-to-have

  • continuous improvement culture
  • Six Sigma tools experience
  • risk-based approach using FMEA
  • strong communication skills
  • attention to detail
  • project management skills

Key Requirements

  • Bachelor's degree in engineering or related technical field preferred
  • 5-10 years validation experience in pharmaceutical manufacturing
  • Knowledge of FDA 21 CFR Parts 201 and 211 and Part 11
  • Training or certifications in regulatory and cGMP requirements desired

Work Rights

Not specified

Tailored Resume

Cover Letter