Lead Validation Engineer, GMP Process Equipment

Katalyst CRO; Evansville (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Senior Validation Engineer to support commissioning, qualification, and validation of GMP-regulated process equipment. You will execute IQ/OQ protocols, perform temperature mapping, and verify equipment for regulatory readiness.

Collaborating with Engineering, QA, and Operations, you will manage documentation, support MOC activities, and help drive continuous improvement in validated systems.

Qualifications

• Bachelor's in STEM or related engineering discipline.
• 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 GMP/GDP documentation practices.
• Experience with IQ/OQ execution, field verification, and equipment qualification.
• Experience with Ellab, eVal, ValGenesis is a plus.
• Exposure to bioprocess equipment preferred.

Responsibilities

• Execute IQ/OQ protocols for process equipment and utility systems.
• Perform drawing walkdowns, including P&ID reviews and system verification activities.
• Conduct equipment verification during commissioning and qualification phases.
• Support Management of Change (MOC) activities and weld verification.
• 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 in qualification/validation.
• Ensure compliant documentation per GMP and GDP requirements.
• Collaborate with Engineering, QA, Manufacturing, and Operations to support validation deliverables.
• Support field verification activities and regulatory compliance.
• Use validation lifecycle systems like eVal; manage docs within validation systems.
• Participate in equipment startup and continuous improvement of validated systems.

Skills

CQV experience

Validation engineering

IQ/OQ execution

GMP/GDP knowledge

eVal experience

ValGenesis

Ellab

documentation practices

cross-functional collaboration

Education

Bachelor's degree in STEM

Tools

eVal

ValGenesis

Ellab

Job description

Katalyst CRO is seeking a Senior Validation Engineer to support commissioning, qualification, and validation of GMP-regulated process equipment. You will execute IQ/OQ protocols, perform temperature mapping, and verify equipment for regulatory readiness.

Collaborating with Engineering, QA, and Operations, you will manage documentation, support MOC activities, and help drive continuous improvement in validated systems.