Sr. Process Validation Engineer

Simtra BioPharma Solutions

Bloomington, Indiana, United States
On-site
Commissioning, qualification, validation (cqv)
Cgmp and regulatory requirements
Develop and execute protocols
The Validation (CQV) Engineer II is a key member of the Engineering team responsible for commissioning, qualification, and validation (CQV) process in accordance with worldwide regulatory agencies

Job Summary

  • The Validation (CQV) Engineer II is a key member of the Engineering team responsible for commissioning, qualification, and validation (CQV) process in accordance with worldwide regulatory agencies.
  • Responsibilities include developing documentation for CQV activities, writing and executing protocols, developing summary reports, tracking validation activities, and managing change controls.
  • Simtra BioPharma Solutions offers a comprehensive benefits package including medical, dental, 401(k) with company match, and a generous time off program.

Matching Summary

The Validation (CQV) Engineer II is a key member of the Engineering team responsible for commissioning, qualification, and validation (CQV) process in accordance with worldwide regulatory agencies.

Skills & Requirements

Must-have

  • Commissioning, Qualification, Validation (CQV)
  • cGMP and regulatory requirements
  • Develop and execute protocols
  • Manage change controls
  • Audit readiness

Nice-to-have

  • Growth mindset
  • Team collaboration
  • High standard of excellence
  • Impact patient health

Key Requirements

  • BS degree in Engineering or Science
  • 2+ years experience in regulated industry CQV
  • Familiarity with ISPE Baseline Guide 5
  • Experience managing multiple projects
  • Strong technical writing skills
  • Advanced Microsoft Office Suite proficiency

Work Rights

Not specified

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