CQV Lead: Biopharma Validation & Commissioning Expert

Trinity Consultants - Advent Engineering; Indiana; Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

Trinity Consultants - Advent Engineering seeks a CQV Lead to drive commissioning, qualification, and validation of biopharma equipment and systems in cGMP environments. You will author and execute comprehensive CQV plans, collaborate across QA, Engineering, and Operations, and ensure timely delivery of compliant documentation.

The role requires extensive hands-on CQV experience, familiarity with DeltaV/PLC/SCADA, and strong regulatory knowledge to support inspections and continuous improvement

Qualifications

• 10+ years of CQV/Validation experience in regulated industries
• Hands-on commissioning and qualification of bioreactors, CIP/SIP, HVAC, WFI
• GDP and FDA regulations knowledge (21 CFR Part 11/210/211) and ICH Q8–Q10
• Strong validation lifecycle and change control understanding
• Experience with automation and process instrumentation for hygienic applications

Responsabilités

• Develop, review, and execute CQV protocols (DQ, FAT, SAT, IQ, OQ, PQ) for process and lab systems
• Generate C&Q plans, URS, risk assessments
• Support start-up/commissioning for biopharma equipment and utilities
• Perform walkdowns, redline P&IDs, verify installations
• Lead risk assessments and design reviews (FAT, HAZOP)
• Coordinate with QA, Engineering, Operations and vendors to ensure timely CQV deliverables
• Compile validation final reports, raw data, deviations, and change controls
• Support regulatory inspections with complete documentation
• Provide process automation support and instrumentation familiarity
• Engage in consulting projects with dynamic schedules

Connaissances

CQV/Validation

Process automation

Regulatory compliance

Troubleshooting

Communication

Project coordination

GDP & FDA regs

Formation

B.S. in Engineering or Life Sciences

Advanced degrees or certifications in validation/quality/project management

Outils

DeltaV

PLC

SCADA

PI Historian

Description du poste

Trinity Consultants - Advent Engineering seeks a CQV Lead to drive commissioning, qualification, and validation of biopharma equipment and systems in cGMP environments. You will author and execute comprehensive CQV plans, collaborate across QA, Engineering, and Operations, and ensure timely delivery of compliant documentation.

The role requires extensive hands-on CQV experience, familiarity with DeltaV/PLC/SCADA, and strong regulatory knowledge to support inspections and continuous improvement