Validation Engineer (SAT)

Katalyst-Healthcares-; Detroit (MI); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Validation expertise

Ferramentas

IQ/OQ protocols

GMP documentation

Deviation management

Requirements traceability

Descrição da oferta de emprego

Job Description:

Our client is seeking a Validation Engineer to lead and support Site Acceptance Testing (SAT) activities for equipment being installed at a new manufacturing facility.

Roles & Responsibilities:

• The consultant will be responsible for developing and executing test protocols, verifying equipment functionality against User Requirements Specifications (URS) and approved design specifications, documenting test results, troubleshooting deficiencies, and coordinating with Original Equipment Manufacturers (OEMs) to resolve technical issues.
• Equipment may include tanks, pumps, filtration systems, chromatography systems, bioreactors, and other process manufacturing equipment.
• The role will involve working directly with engineering, automation, quality, and vendor teams to confirm equipment is installed, operates as intended, and is ready for subsequent qualification and startup activities.
• A strong validation background is essential, including experience with commissioning and qualification (C&Q), IQ/OQ protocols, GMP documentation, requirements traceability, deviation management, and equipment qualification within pharmaceutical or biotechnology manufacturing environments.
• The ideal candidate will be comfortable reviewing vendor documentation, identifying gaps between design requirements and actual equipment performance, documenting discrepancies, and driving issues through resolution.
• Experience supporting FATs, SATs, risk assessments, and equipment handover into formal qualification is highly desirable.