C&Q

Summary

JC Automation provides automation, control systems integration, information technology, system integration, and regulatory compliance services for life science manufacturing. The Commissioning & Qualification Engineer plans, executes, and documents commissioning and qualification activities for facilities, utilities, equipment, and manufacturing systems in regulated environments, ensuring installation, performance, documentation, and compliance requirements are met.

Responsibilities

• Develop and execute C&Q protocols, including FAT/SAT and IQ/OQ/PQ
• Review URS, specifications, drawings, P&IDs, and vendor documentation
• Verify equipment installation and functional performance
• Perform field inspections, testing, and system verification
• Manage discrepancies, punch-list items, and deviations
• Prepare qualification reports and turnover documentation
• Support startup, troubleshooting, and operational readiness
• Ensure compliance with GMP and site quality requirements

Skills

• Bachelor's degree in Engineering, Science, or related technical discipline
• Experience in commissioning, qualification, validation, engineering, or equipment startup within pharmaceutical, biotechnology, medical device, or regulated manufacturing environments
• Knowledge of GMP requirements and qualification lifecycle principles
• Experience developing and executing commissioning and qualification protocols
• Ability to read and interpret P&IDs, electrical drawings, equipment specifications, and engineering documents
• Understanding of equipment, utilities, instrumentation, control systems, and manufacturing processes
• Strong technical writing, troubleshooting, analytical, and documentation skills
• Ability to perform field activities and collaborate with multidisciplinary project teams
• Experience with process equipment, clean utilities, HVAC, purified water/WFI, compressed gases, manufacturing equipment, or automation systems
• Knowledge of ASTM E2500, ISPE guidance, and risk-based qualification approaches
• Experience with FAT, SAT, commissioning, IQ/OQ/PQ, and system turnover
• Familiarity with electronic C&Q platforms such as Kneat or similar systems
• Experience supporting equipment startup and troubleshooting in pharmaceutical manufacturing environments
• Knowledge of instrumentation, PLC/HMI systems, and automation interfaces
• Experience supporting regulatory inspections and quality audits

Qualifications

Must Haves

• Bachelor's degree in Engineering, Science, or related technical discipline
• Experience in commissioning, qualification, validation, engineering, or equipment startup within pharmaceutical, biotechnology, medical device, or regulated manufacturing environments
• Knowledge of GMP requirements and qualification lifecycle principles
• Experience developing and executing commissioning and qualification protocols
• Ability to read and interpret P&IDs, electrical drawings, equipment specifications, and engineering documents
• Understanding of equipment, utilities, instrumentation, control systems, and manufacturing processes
• Strong technical writing, troubleshooting, analytical, and documentation skills
• Ability to perform field activities and collaborate with multidisciplinary project teams

Nice to Haves

• Experience with process equipment, clean utilities, HVAC, purified water/WFI, compressed gases, manufacturing equipment, or automation systems
• Knowledge of ASTM E2500, ISPE guidance, and risk-based qualification approaches
• Experience with FAT, SAT, commissioning, IQ/OQ/PQ, and system turnover
• Familiarity with electronic C&Q platforms such as Kneat or similar systems
• Experience supporting equipment startup and troubleshooting in pharmaceutical manufacturing environments
• Knowledge of instrumentation, PLC/HMI systems, and automation interfaces
• Experience supporting regulatory inspections and quality audits