Pharma C&Q Engineer — Commissioning & Qualification Expert

JC Automation; San Lorenzo (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

JC Automation Corp. (JCA) is seeking a Commissioning & Qualification Engineer to plan, execute, and document commissioning activities for regulated facilities, utilities, equipment, and manufacturing systems.

They ensure systems are properly installed, operate as intended, and meet approved design, quality, and regulatory requirements before release for operational use. Focus: commissioning, qualification, testing, and turnover of equipment, utilities, and systems.

Qualifications

• 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.

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

Technical writing

Troubleshooting

Analytical skills

Documentation

Field activities

Regulatory understanding

Education

Bachelor’s degree in Engineering, Science

Tools

Kneat

Job description

JC Automation Corp. (JCA) is seeking a Commissioning & Qualification Engineer to plan, execute, and document commissioning activities for regulated facilities, utilities, equipment, and manufacturing systems.

They ensure systems are properly installed, operate as intended, and meet approved design, quality, and regulatory requirements before release for operational use. Focus: commissioning, qualification, testing, and turnover of equipment, utilities, and systems.