Validation Engineer: SAT & C&Q for Biotech GMP Equipment

Katalyst-Healthcares-; Detroit (MI); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Katalyst-Healthcares- seeks a Validation Engineer to lead SAT activities for equipment at a new manufacturing facility. You will develop and execute test protocols, verify functionality against URS, document results, and coordinate with OEMs to resolve technical issues.

The role requires a strong validation background, including C&Q, IQ/OQ protocols, GMP documentation, and deviation management in pharma/biotech environments.

Qualifications

• Extensive validation background in pharmaceutical/biotech manufacturing.
• Experience with commissioning and qualification (C&Q) is required.
• Familiarity with FATs, SATs, risk assessments and equipment handover.

Responsabilités

• Develop and execute test protocols; verify equipment against URS and design specs.
• Document test results and troubleshoot deficiencies; coordinate with OEMs to resolve issues.
• Review vendor documentation and identify gaps between design requirements and equipment performance.
• Support FATs, SATs, risk assessments, and qualification handovers.

Connaissances

Validation expertise

Outils

IQ/OQ protocols

GMP documentation

Deviation management

Requirements traceability

Description du poste

Katalyst-Healthcares- seeks a Validation Engineer to lead SAT activities for equipment at a new manufacturing facility. You will develop and execute test protocols, verify functionality against URS, document results, and coordinate with OEMs to resolve technical issues.

The role requires a strong validation background, including C&Q, IQ/OQ protocols, GMP documentation, and deviation management in pharma/biotech environments.