Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Senior CQV Engineer/Senior Validation Engineer Consultant

Devens, MA, US • Posted 1 day ago • Updated 10 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

  • Drawing
  • P&ID
  • Regulatory Compliance
  • SIP
  • Collaboration
  • Quality Assurance
  • Manufacturing
  • Project Implementation
  • Lifecycle Management
  • Document Management
  • Startups
  • Continuous Improvement
  • Biomedical Engineering
  • Chemical Engineering
  • GMP
  • GDP
  • Documentation
  • IQ
  • OQ
  • Management
  • Mapping
  • Chromatography

Summary

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:
  • 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: a42745660a1ce08cad9a6218de59369
  • Posted 1 day ago
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