CQV Engineer

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. The 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 Cap Ex 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 clean rooms.
• Utilize electronic validation management systems such as Veeva, Kneat, or Val Genesis 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, Val Genesis).
• 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.