CQV Lead Engineer

CQV Engineer – Equipment & Utilities Validation

Experience Level: 8 years

Industry: Pharma / Biotech / Life Sciences

Job Summary

The CQV Engineer is responsible for the planning, execution, and documentation of commissioning, qualification, and validation activities for GMP equipment and utilities in regulated pharmaceutical and biotechnology manufacturing environments.

This role focuses on physical assets such as process equipment, clean utilities, and facility systems.

Key Responsibilities

Equipment & Utilities Qualification

• Lead and execute IQ, OQ, and PQ activities for GMP equipment and utilities, including:
• Process equipment
• Clean utilities (WFI, clean steam, compressed gases)
• Facility systems and HVAC
• Support commissioning activities and system turnover from Engineering to Quality.
• Perform system impact assessments, criticality assessments, and risk evaluations for equipment and utilities.
• Review and approve vendor documentation, drawings, manuals, and FAT/SAT packages related to equipment qualification.

Validation Documentation & Compliance

• Author, execute, and review DQ, IQ, OQ, PQ protocols and final reports for equipment and utilities.
• Ensure compliance with FDA 21 CFR Parts 210/211, EU GMP Annex 15, and applicable industry guidance.
• Support deviations, discrepancy management, and change controls related to validated equipment.
• Maintain validation lifecycle documentation and support periodic review and requalification activities.

Cross-Functional Collaboration

• Work closely with Engineering, Facilities, Manufacturing, and Quality teams during project execution and startup.
• Provide CQV input during equipment design reviews, installation planning, and operational readiness activities.
• Support regulatory inspections and internal audits related to equipment qualification.

Continuous Improvement & Leadership

• Drive improvements to equipment qualification templates, protocols, and execution strategies.
• Mentor junior CQV engineers and provide technical guidance on equipment and utility systems.
• Promote risk-based and science-based validation approaches for physical systems.

Required Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• 8 years of hands-on experience in equipment and utilities qualification in a GMP-regulated environment.
• Demonstrated experience executing IQ/OQ/PQ for equipment and utilities.
• Strong knowledge of GMP regulations applicable to equipment qualification.
• Proven experience supporting regulatory inspections focused on equipment validation.
• Excellent technical writing and documentation skills.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, or aseptic processing environments.
• Hands-on qualification of clean utilities (WFI, clean steam, HVAC).
• Familiarity with ASTM E2500 and risk-based qualification methodologies.
• Experience supporting capital projects, expansions, or tech transfers.