Senior Validation Engineer

Katalyst CRO; Rock Hill (SC); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Rock Hill, SC is seeking a Senior Validation Engineer to lead IQ/OQ execution, qualification of process equipment, and GMP/GDP-compliant documentation. You will collaborate with Engineering, QA, and Manufacturing to ensure validated systems perform reliably.

The role requires CQV experience, hands-on validation of bioprocess equipment, and the ability to support second-shift or weekend work as needed. This position emphasizes quality, compliance, and continuous improvement.

Qualifications

• Bachelor's degree in STEM or related technical discipline.
• 38 years of CQV or Validation Engineering experience in GMP-regulated environments.

Responsibilities

• Execute IQ/OQ protocols for process equipment and utilities.
• Perform drawing walkdowns and P&ID reviews for equipment installation.
• Support MOC activities and weld verification as part of validation.

Skills

IQ/OQ execution

P&ID reviews

MOC support

Temperature mapping

SIP/CIP validation

Deviation management

GMP/GDP compliance

Cross-functional collaboration

Education

Bachelor's degree in STEM or related

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.