Senior Validation Engineer - GMP CQV Specialist

Katalyst CRO; Evansville (IN); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a Senior Validation Engineer to drive IQ/OQ validation of GMP process equipment and utilities. You will perform temperature mapping, SIP/CIP validation, and document adherence to GMP/GDP standards while coordinating with Engineering, QA, Manufacturing, and Operations.

The role requires hands-on CQV experience, strong documentation practices, and ability to support second-shift and weekend work as needed, contributing to commissioning, qualification, and continuous

Competenze

• Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or related technical discipline preferred.
• 38 years of CQV (Commissioning, Qualification & Validation) and/or Validation Engineering experience in GMP-regulated industries.
• Hands‑on experience executing validation activities for process equipment and utility systems.
• Strong understanding of GMP/GDP requirements and validation documentation practices.
• Experience with IQ/OQ execution, field verification, and equipment qualification activities.
• Proficiency with eVal validation management system; experience with ValGenesis is a plus.
• Exposure to temperature mapping activities and validation tools such as Ellab preferred.
• Experience working with bioprocess equipment including bioreactors, filtration systems, chromatography systems, and ultrafiltration (UF) preferred.
• Ability to support second‑shift operations and weekend work as required.

Mansioni

• Execute IQ/OQ protocols for process equipment and utility systems.
• Perform drawing walkdowns and P&ID reviews for installation verification.
• Conduct equipment verification during commissioning and qualification phases.
• Support MOC activities and weld verification as part of validation.
• Perform temperature mapping studies using data loggers and Ellab tools.
• Assist with SIP/CIP execution, cycle development, and validation activities.
• Identify, document, and investigate deviations during qualification and validation.
• Ensure compliant documentation per GMP and GDP standards.
• Collaborate with Engineering, QA, Manufacturing, and Operations to deliver validation deliverables.
• Support field verification activities and ensure regulatory compliance.
• Utilize validation lifecycle management systems (eVal, ValGenesis) and document management within validation systems.
• Participate in equipment startup, readiness, and continuous improvement initiatives.

Conoscenze

IQ/OQ execution

Validation activities

Documentation practices

Cross-functional collaboration

Second-shift weekend readiness

Formazione

Bachelor's degree in STEM/Engineering

Strumenti

eVal

ValGenesis

Ellab

Descrizione del lavoro

Katalyst CRO is seeking a Senior Validation Engineer to drive IQ/OQ validation of GMP process equipment and utilities. You will perform temperature mapping, SIP/CIP validation, and document adherence to GMP/GDP standards while coordinating with Engineering, QA, Manufacturing, and Operations.

The role requires hands-on CQV experience, strong documentation practices, and ability to support second-shift and weekend work as needed, contributing to commissioning, qualification, and continuous