CQV Lead

The CQV Lead is responsible for the commissioning, qualification, and validation of facilities, utilities, process and laboratory equipment, and computerized systems to ensure compliance with cGMP regulations and internal quality standards. This role involves authoring and executing CQV protocols (IQ, OQ, PQ), coordinating with cross-functional teams, troubleshooting deviations, and preparing documentation in support of regulatory requirements. The position plays a key role in delivering compliant operational systems for manufacturing and laboratory environments.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Develop, review, and execute Commissioning, Qualification, and Validation (CQV) protocols including DQ, FAT, SAT, IQ, OQ, and PQ for biopharmaceutical process, facilities/utilities systems and Process/laboratory equipment. Generate strategic documentations such as C&Q Plans, user requirement specifications (URS), risk assessments. Support start-up and commissioning activities for upstream, downstream bulk processing equipment (bioreactors/fermenters, chromatography skids, bioreactors, TFF, UFDF, centrifuge etc.), solid/ oral dosage equipment (tablet press, powder compactors, coating pans, compounding skids for mixing, etc.), critical utilities (WFI, process gases, pure steam, etc.), FFIP (formulation equipment, isolators, fillers, lyophilizer, etc.), and/or equipment used in Single Use application (e.g., SUBs, SUM, etc.) Perform equipment walkdowns, redline P&IDs, and verify component installations. Participate in and/or lead risk assessments and design reviews (FAT, HAZOP, etc.). Coordinate with Quality Assurance, Engineering, Operations, and vendors to ensure timely execution of CQV deliverables. Identify and troubleshoot system discrepancies or failures during commissioning and qualification. Ensure adherence to project timelines and maintain clear communication across stakeholders. Generate and compile validation final reports, raw data, deviation records, and change controls. Support regulatory inspections by ensuring all validation documentation is complete and readily available. General working experience in Process Automation to support control narrative and sequences Familiarity in process instrumentation and components for hygienic application Familiarity with ASME BPE standards, ASTM E2500 risk-based C&Q strategies, ISPE and USFDA regulatory requirements.

SUPERVISORY RESPONSIBILITIES

May directly supervise a number of technical/CQV team members during Commissioning and Qualification phase of the project.

QUALIFICATIONS

10+ years of experience in CQV or Validation within a regulated industry (pharmaceuticals, biotech, medical devices). Hands‑on experience with commissioning and qualification of systems such as bioreactors, chromatography skids, CIP/SIP systems, HVAC, WFI, Clean Steam, autoclaves, etc. Proficiency with Good Documentation Practices (GDP), FDA regulations (21 CFR Part 11/210/211), ICH Q8‑Q10, ISPE Baseline Guides (e.g., GAMP 5). Strong understanding of validation lifecycle and change control processes. Experience working with Delta V, PLC, SCADA, or other automation systems and PI Historian preferred. Excellent written and verbal communication skills. Strong analytical, organizational, and time‑management skills. Strong troubleshooting skills to resolve issues and deviations observed during commissioning and qualification. Team‑oriented but requires ability to work independently under limited supervision. Experience in consulting environment and engaging clients in projects that may have a dynamic schedule while multi‑tasking other responsibilities is an asset. EDUCATION and/or EXPERIENCE Bachelor’s degree (B.S.) in Engineering (Mechanical, Chemical, Electrical, Biomedical) or Life Sciences (Biology, Chemistry, Pharmacy) from four‑year college or university or foreign equivalent. Advanced degrees or certifications in validation, quality, or project management (e.g., ASQ, ISPE) are a plus. Experience in consulting in Life Science industry and participate in delivering successful large‑scale Engineering projects. Must have computer literacy, including word processing, spreadsheet skills, and knowledge of Microsoft Office software package. #J-18808-Ljbffr Trinity Consultants - Advent Engineering