Senior CQV Automation Engineer

Base pay range

$/yr - $/yr

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 Plant

PAx preferred) and involves designing validation protocols, troubleshooting controls, and implementing reliable, efficient automation solutions.

Responsibilities:

• 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.
• Proactively plan and manage automation commissioning and integration activities.
• Provide input on project timelines and ensure alignment with overall facility schedules for both Cap Ex and OpEx initiatives.
• 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.
• 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.
• 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 Plant
  
  PAx 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, clean rooms) and systems using Unicorn software.
• Experience with electronic validation management systems (e.g., Veeva, Kneat, Val Genesis) 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.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Pharmaceutical Manufacturing