CQV Project Engineer (GMP / Commissioning & Qualification)

United Pharma; Piscataway Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma in Piscataway, NJ, seeks a Validation Specialist to support qualification activities for manufacturing equipment, facilities, and utilities during a high-priority site startup. You will draft and execute FAT/IQ/OQ/PQ protocols and partner with Maintenance, Engineering, Quality, and external vendors.

The role requires 2+ years in a cGMP environment, knowledge of GDP and FDA regulations, and the ability to manage schedules and generate progress reports. Weekend hours may be required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• 2+ years of validation/qualification experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong working knowledge of GDP, FDA regulations, and risk-based validation principles.
• Proven ability to draft/execute protocols, analyze test data, document discrepancies, and manage vendor schedules.
• Flexibility to work occasional weekend hours as required by project and vendor schedules.

Responsibilities

• Design, review, and execute FAT, IQ, OQ, and PQ protocols for GMP equipment, utilities, and facilities.
• Act with a project management mindset to schedule vendors, manage tight timelines, and track validation deliverables.
• Perform re-qualification activities and write detailed technical investigation reports for non-conformances.
• Partner closely with Maintenance, Engineering, Quality, and external vendors to ensure seamless installation and commissioning.
• Generate weekly and monthly validation progress reports to keep project schedules on track.

Skills

Good Manufacturing Practices (GMP)

Equipment Validation

Education

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field

Job description

Are you a driven validation professional looking to make an immediate impact on a major GMP facility expansion? A leading global pharmaceutical company is seeking a Validation Specialist to support critical qualification activities for manufacturing equipment, facilities, and utilities during a high-priority site startup.

Responsibilities

• Design, review, and execute FAT, IQ, OQ, and PQ protocols for GMP equipment, utilities, and facilities.
• Act with a project management mindset to schedule vendors, manage tight timelines, and track validation deliverables.
• Perform re-qualification activities and write detailed technical investigation reports for non-conformances.
• Partner closely with Maintenance, Engineering, Quality, and external vendors to ensure seamless installation and commissioning.
• Generate weekly and monthly validation progress reports to keep project schedules on track.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• 2+ years of validation/qualification experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong working knowledge of GDP, FDA regulations, and risk-based validation principles.
• Proven ability to draft/execute protocols, analyze test data, document discrepancies, and manage vendor schedules.
• Flexibility to work occasional weekend hours as required by project and vendor schedules.

skills:

Good Manufacturing Practices (GMP), Equipment Validation