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cqv astm e2500 validation lifecycle ispe baseline guides annex 15📋 Description
- Lead NA market expansion and growth for Validation Management.
- Provide thought leadership to field-facing teams and exec leadership.
- Guide product strategy to address qualification of assets and processes.
- Develop messaging to drive customer adoption to data-centric validation.
- Coordinate resources across the customer lifecycle from discovery to delivery.
- Serve as industry evangelist via conferences, webinars, and content.
🎯 Requirements
- 5+ years in life sciences validation focusing on commissioning, qualification, and validation of manufacturing equipment.
- Deep technical understanding of the validation lifecycle for facilities, utilities, and process equipment.
- Experience with risk-based qualification and standards such as ASTM E2500, ISPE Baseline Guides, and Annex 15.
- Proven ability to move organizations from document-centric to data-centric validation.
- Experience implementing or consulting on digital validation software for field execution and asset state management.
- Bachelor’s degree in Engineering and ability to travel up to 40%.
🎁 Benefits
- Medical, dental, vision, and basic life insurance.
- Flexible PTO and company paid holidays.
- Retirement programs.
- 1% charitable giving program.
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