Senior Validation Engineer

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

Job Description

Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams.

Responsibilities

• Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for process equipment and utility systems.
• Perform drawing walkdowns, including P&ID reviews and system verification activities to ensure equipment installation compliance.
• Conduct equipment and component verification activities during commissioning and qualification phases.
• Support Management of Change (MOC) activities and perform weld verification as part of validation and compliance processes.
• Perform and support temperature mapping studies using data loggers and validation tools such as Ellab.
• Assist with Steam-In-Place (SIP) and Clean-In-Place (CIP) execution, cycle development, and validation activities.
• Identify, document, and investigate deviations encountered during qualification and validation activities.
• Ensure accurate, complete, and compliant documentation in accordance with GMP and GDP requirements.
• Collaborate cross-functionally with Engineering, Quality Assurance (QA), Manufacturing, and Operations teams to support project execution and validation deliverables.
• Support field verification activities and ensure validation activities meet regulatory and quality standards.
• Utilize validation lifecycle management systems such as eVal and support documentation management within validation systems.
• Participate in equipment startup, operational readiness, and continuous improvement initiatives for validated systems and processes.

Requirements

• Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a 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.