About this opportunity
United Pharma lists this CQV Project Engineer (GMP / Commissioning & Qualification) opportunity in piscataway, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
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
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.