What are the responsibilities and job description for the Senior CQV Engineer/Senior Validation Engineer Consultant position at Katalyst Healthcares and Lifesciences?
Job Summary:
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:
Education & Experience:
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.
Education & Experience:
- Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a related technical discipline preferred.
- 3-8 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.