What are the responsibilities and job description for the CQV Engineer position at Katalyst CRO?
Job Summary
- The CQV Automation Engineer is responsible for executing and documenting automation commissioning, qualification, and testing activities within a GMP biotech or pharmaceutical manufacturing environment.
- This role supports automated systems, control equipment, and plant-wide automation networks while ensuring compliance with cGMP, GDP, and regulatory standards.
- The position requires close collaboration with cross-functional teams and on-site support during commissioning and operational phases.
- Independently develop, configure, test, and document automated systems and control equipment including PLCs, HMIs, and plant-wide automation networks in compliance with cGMP and GDP requirements
- Analyze system performance, generate technical reports, and ensure regulatory-compliant documentation
- Plan and manage automation commissioning and integration activities while aligning with facility schedules for CapEx and OpEx initiatives
- Act as the automation representative on project teams, coordinating with Engineering, QA, Operations, and Validation groups
- Review and interpret URS, FS, P&IDs, and SOPs to develop system architectures and testing strategies
- Translate specifications into functional test cases and ensure requirements are fully verified and documented
- Communicate automation status, risks, and corrective actions clearly and timely
- Troubleshoot automation system issues during commissioning and operational phases and implement corrective solutions
- Perform chamber temperature mapping, worst-case load justification, and periodic requalification reviews
- Support cleaning validation activities including cleaning cycle development, rinse sampling, surface swabbing, and visual inspections
- Execute qualification and testing of process equipment such as synthesizers, UF systems, HPLC, lyophilizers, CIP, WFI, clean utilities, and cleanrooms
- Utilize electronic validation management systems such as Veeva, Kneat, or ValGenesis and support testing using PLC logic and regression analysis
- Support automation system commissioning outside standard business hours as required
- Bachelor's degree in a STEM field (Biomedical, Chemical, Electrical, or Mechanical Engineering preferred) or equivalent experience
- Minimum of 5 years of hands-on experience in automation commissioning, control system implementation, and process equipment integration in a GMP biotech or pharmaceutical manufacturing environment
- Hands-on experience with automation commissioning and qualification, including automated manufacturing equipment (Rockwell Plant PAx preferred)
- Experience with electronic validation management systems (Veeva, Kneat, ValGenesis)
- Strong proficiency in Good Documentation Practices and regulatory compliance
- Proven ability to manage, prioritize, and execute multiple automation projects simultaneously
- Ability to meet on-site work requirements in Norton, MA
- Willingness to work on-site outside standard business hours as needed