C&Q Engineer: GMP Validation & System Turnover

ADP, Inc.; San Lorenzo (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

JC Automation Corp. in the life sciences sector seeks a Commissioning & Qualification Engineer to plan, execute, and document commissioning and qualification activities for facilities, utilities, equipment, and manufacturing systems within regulated environments.

You will develop and execute FAT/SAT and IQ/OQ/PQ protocols, review URS and drawings, verify installation and performance, manage discrepancies, and ensure GMP compliance while supporting startup and operations readiness.

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• Experience in commissioning, qualification, validation, engineering, or equipment startup in regulated environments.
• Knowledge of GMP and qualification lifecycle principles.
• Ability to read and interpret P&IDs, electrical drawings, equipment specifications, and engineering documents.
• 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

GMP knowledge

Reading P&IDs & drawings

Technical writing

Problem solving

Team collaboration

Education

Bachelor’s degree in Engineering/Science

Tools

Kneat or similar C&Q platform

Job description

JC Automation Corp. in the life sciences sector seeks a Commissioning & Qualification Engineer to plan, execute, and document commissioning and qualification activities for facilities, utilities, equipment, and manufacturing systems within regulated environments.

You will develop and execute FAT/SAT and IQ/OQ/PQ protocols, review URS and drawings, verify installation and performance, manage discrepancies, and ensure GMP compliance while supporting startup and operations readiness.