C&Q

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

A Commissioning & Qualification (C&Q) Engineer is responsible for planning, executing, and documenting commissioning and qualification activities for facilities, utilities, equipment, and manufacturing systems within regulated environments. They ensure systems are properly installed, operate as intended, and meet approved design, quality, and regulatory requirements before release for operational use.

Focus: Focuses on commissioning, qualification, testing, and turnover of equipment, utilities, and systems. Emphasizes technical execution, documentation accuracy, system readiness, regulatory compliance, and verification against approved requirements and specifications.

RESPONSIBILITIES

1.Develop and execute C&Q protocols, including FAT/SAT and IQ/OQ/PQ.

2.Review URS, specifications, drawings, P&IDs, and vendor documentation.

3. Verify equipment installation and functional performance.

4. Perform field inspections, testing, and system verification.

5. Manage discrepancies, punch-list items, and deviations.

6. Prepare qualification reports and turnover documentation.

7. Support startup, troubleshooting, and operational readiness.

8. Ensure compliance with GMP and site quality requirements.

REQUIREMENTS & QUALIFICATIONS

Required

1. Bachelor’s degree in Engineering, Science, or related technical discipline.

2. Experience in commissioning, qualification, validation, engineering, or equipment startup within pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.

3. Knowledge of GMP requirements and qualification lifecycle principles.

4. Experience developing and executing commissioning and qualification protocols.

5. Ability to read and interpret P&IDs, electrical drawings, equipment specifications, and engineering documents.

6. Understanding of equipment, utilities, instrumentation, control systems, and manufacturing processes.

7. Strong technical writing, troubleshooting, analytical, and documentation skills.

8. Ability to perform field activities and collaborate with multidisciplinary project teams.

Preferred

1. Experience with process equipment, clean utilities, HVAC, purified water/WFI, compressed gases, manufacturing equipment, or automation systems.

2. Knowledge of ASTM E2500, ISPE guidance, and risk-based qualification approaches.

3. Experience with FAT, SAT, commissioning, IQ/OQ/PQ, and system turnover.

4. Familiarity with electronic C&Q platforms such as Kneat or similar systems.

5. Experience supporting equipment startup and troubleshooting in pharmaceutical manufacturing environments.

6. Knowledge of instrumentation, PLC/HMI systems, and automation interfaces.

7. Experience supporting regulatory inspections and quality audits.