Senior Validation Engineer

Katalyst CRO; Evansville (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

IQ/OQ execution

Validation activities

Documentation practices

Cross-functional collaboration

Second-shift weekend readiness

Education

Bachelor's degree in STEM/Engineering

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.

• 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

Roles & 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.