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CQV Engineer

Katalyst CRO • Norton, MA, US • 6h ago

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.

Roles & Responsibilities

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

Education & Experience

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