CQV Automation Engineer​/Senior Automation Engineer

Norton, MA

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

We are seeking a mid-to-senior level Automation Engineer to support Opex and Capex projects in a pharmaceutical manufacturing facility, focusing on the commissioning, qualification, and optimization of automated process equipment and control systems. The role requires experience with plant automation systems (Rockwell PAx preferred) and involves designing validation protocols, troubleshooting controls, and implementing reliable, efficient automation solutions.

• 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 Cap Ex 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:

• Automation & Control Systems
  
  Experience:
  
  Hands-on experience with automation commissioning and qualification, including operation of automated manufacturing equipment (Rockwell Plant PAx preferred)
• Thermal Mapping & Requalification:
  Experience performing chamber temperature mapping, worst-case load justification, and periodic requalification reviews to confirm the validated state
• Cleaning Validation Expertise:
  Experience with cleaning cycle development, rinse sampling, surface swabbing, and visual inspections to support cleaning validation or verification
• Equipment & Software Exposure:
  Prior qualification/testing experience with process equipment (e.g., synthesizers, UF, HPLC, lyophilizers, CIP, WFI, clean utilities, clean rooms) and systems using Unicorn software
• Validation Systems & PLC Familiarity:
  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…