Senior Validation Engineer Consultant

Katalyst CRO; Harvard (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for GMP-regulated process equipment. You will execute IQ/OQ protocols, perform temperature mapping, and support SIP/CIP validation, while ensuring documentation compliance across QA, Engineering, and Operations teams.

Ideal candidates bring hands-on CQV experience, familiarity with eVal/ValGenesis and Ellab, and a willingness to support second-shift or weekend work as needed.

Qualifications

• Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a related technical discipline preferred.
• Hands-on CQV/Validation engineering experience in GMP-regulated environments.
• Experience executing IQ/OQ, field verification, and validation documentation practices.
• Exposure to equipment startup, integration, and cross-functional collaboration.

Responsibilities

• Execute IQ and 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 MOC activities and weld verification as part of validation processes.
• Perform temperature mapping studies using data loggers and validation tools such as Ellab.
• Assist with SIP/CIP execution, cycle development, and validation activities.
• Identify, document, and investigate deviations encountered during qualification and validation activities.
• Ensure compliant documentation according to GMP and GDP requirements.
• Collaborate with Engineering, QA, Manufacturing, and Operations to support deliverables.
• Support field verification activities to meet regulatory and quality standards.
• Utilize validation lifecycle management systems such as eVal and ValGenesis.
• Participate in equipment startup and continuous improvement initiatives for validated systems.

Job description

Job Description

Senior CQV Engineer / 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.

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.