CQV Lead

Trinity Consultants - Advent Engineering; Indiana; On-site; USD 120,000 - 150,000; Full time

Job summary

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

Responsibilities

• 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

Skills

CQV/Validation

Process automation

Regulatory compliance

Troubleshooting

Communication

Project coordination

GDP & FDA regs

Education

B.S. in Engineering or Life Sciences

Advanced degrees or certifications in validation/quality/project management

Tools

DeltaV

PLC

SCADA

PI Historian

Job description

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered

SUMMARY

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.