Job Description

A leading pharmaceutical facility is expanding its operations and seeking an experienced CQV Lead/Manager to spearhead commissioning and qualification efforts on a major strategic capital project. The site is undergoing a multi-year transformation to significantly increase production capacity through upgrades in manufacturing, utilities, and component handling infrastructure.

Role Overview

Reporting into the CQV function, the CQV Lead will be responsible for managing and coordinating all commissioning and qualification activities, including direct oversight of a team of CQV engineers and cross-functional collaboration with engineering, operations, quality, EHS, logistics, and digital functions.

Key Responsibilities

• Lead and coordinate a team of 10+ CQV Engineers, ensuring timely execution and adherence to SOPs and current industry standards.
• Oversee the transition to a digitized CQV platform (e.g., Kneat Solutions) and support implementation activities.
• Develop and maintain CQV project plans, schedules, and budgets, aligning with overall business objectives.
• Ensure full lifecycle qualification of equipment and systems (FAT, SAT, URS, DQ, IQ, OQ, PQ).
• Manage and coordinate all CQV documentation including URS, FS, TS, risk assessments, SAT/COMM plans, and protocol execution.
• Proactively identify and mitigate project risks to ensure project milestones and compliance standards are met.
• Lead project meetings, facilitate technical discussions, and provide regular reporting to senior stakeholders.
• Ensure all vendors and internal teams comply with CQV protocols, regulatory requirements, and site procedures.
• Drive continuous improvement by leveraging best practices in quality, validation, and risk-based approaches (e.g., ASTM E2500, ISPE Baseline Guides).

Qualifications & Experience

• Degree-qualified or equivalent with 10+ years’ experience in pharmaceutical or biotech validation.
• Minimum 5 years in a CQV lead role, with team leadership and cross-functional project management experience.
• Proven experience managing CQV teams or major capital projects in a fast-paced, regulated environment.
• Expertise with digitized validation platforms (e.g., Kneat).
• In-depth knowledge of Risk-Based Validation (RBV) aligned with ISPE and regulatory expectations.
• Strong understanding of EU and global regulatory guidelines for GxP systems.
• Skilled in stakeholder management, decision-making, planning, and written/verbal communication.
• Familiar with ASTM E2500, Annex 15, and current regulatory trends in commissioning and qualification.