Senior CQV Automation Engineer
CQV Automation Engineer / Senior Automation Engineer
Location: Norton, MA
Description
The organization is seeking a mid-to-senior level Automation Engineer to support Opex and Capex projects in a pharmaceutical manufacturing facility. This role focuses on the commissioning, qualification, and optimization of automated process equipment and control systems. The position requires experience with plant automation systems (Rockwell PlantPAx preferred) and involves designing validation protocols, troubleshooting controls, and implementing reliable, efficient automation solutions.
Responsibilities
Automation Execution & Documentation:
- Independently develop, configure, and test automated systems and control equipment, including PLCs, HMIs, and plant-wide automation networks.
- Analyze system performance, generate technical reports, and ensure all documentation meets cGMP, GDP, and regulatory standards.
Project Planning & Scheduling:
- Proactively plan and manage automation commissioning and integration activities.
- Provide input on project timelines and ensure alignment with overall facility schedules for both CapEx and OpEx initiatives.
Cross-Functional Collaboration:
- Serve as the automation representative on project teams, coordinating with Engineering, QA, Operations, and Validation teams to deliver robust, compliant, and reliable automation solutions on schedule.
Technical Interpretation & Testing Strategy:
- Review and interpret technical documentation (e.g., URS, FS, P&IDs, SOPs) to develop system architecture and testing strategies.
- Translate specifications into functional test cases and ensure all automation requirements are fully verified and documented.
Communication & Troubleshooting:
- Provide clear and timely updates on automation status, risks, and corrective actions.
- Independently troubleshoot system issues during commissioning and operational phases, implement solutions, and maintain optimized and compliant automated systems.
Preferred Experience
- Hands-on experience with automation commissioning and qualification, including operation of automated manufacturing equipment (Rockwell PlantPAx preferred).
- Experience performing chamber temperature mapping, worst-case load justification, and periodic requalification reviews to confirm the validated state.
- Experience with cleaning cycle development, rinse sampling, surface swabbing, and visual inspections to support cleaning validation or verification.
- Prior qualification/testing experience with process equipment (e.g., synthesizers, UF, HPLC, lyophilizers, CIP, WFI, clean utilities, cleanrooms) and systems using Unicorn software.
- Experience with electronic validation management systems (e.g., Veeva, Kneat, ValGenesis) and familiarity with PLC code/ladder logic to support testing and regression analysis.
Requirements
- Must be able to meet on-site work requirements in Norton, MA.
- Bachelor's degree in a STEM field (Biomedical, Chemical, Electrical, or Mechanical Engineering preferred) or equivalent experience.
- 5+ years of hands-on experience in automation commissioning, control system implementation, and process equipment integration in a GMP biotech or pharmaceutical manufacturing environment.
- Proven ability to manage, prioritize, and execute multiple automation projects simultaneously, ensuring on-time delivery and compliance.
- Strong proficiency in Good Documentation Practices and regulatory compliance within automated system development and operation.
- Willingness to work on-site outside standard business hours as needed to support system commissioning, troubleshooting, and optimization activities.
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