CQV Lead

The CQV Lead is responsible for the planning, execution, and management of commissioning, qualification, and validation activities for projects. This role ensures that all systems, equipment, and processes are commissioned and qualified according to regulatory requirements, industry standards, and client specifications. The CQV Lead provides technical guidance, manages cross‑functional teams, and liaises with project stakeholders to ensure successful project delivery.

Key Responsibilitie

sOversee the development and execution of CQV strategies, plans, and protocols (IQ/OQ/PQ) for new facilities, utilities, process equipment, and systems

.Lead and coordinate CQV team members, including engineers, consultants, and contractors, to ensure timely completion of deliverables

.Liaise with design, engineering, construction, quality, and operations teams to align CQV activities with project milestones

.Review and approve CQV documents such as URS, FAT/SAT, risk assessments, test protocols, and final reports

.Ensure compliance with current Good Manufacturing Practices (cGMP), FDA, EMA, and other relevant regulatory standards and guidelines

.Manage deviations, change controls, and corrective actions related to CQV activities

.Organize and perform system walk-downs, punch‑list generation/closure, and readiness reviews

.Represent CQV in project meetings, client audits, and regulatory inspections as required

.Plan project schedules, resource allocation, and report on CQV progress and KPIs

.Train, mentor, and support development of junior CQV staff

Qualifications & Experien

ce Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Process, or related field), Life Sciences, or equivalen

t.Minimum of 7 years’ experience in CQV roles within pharmaceutical, biotechnology, or related industrie

s.Demonstrated experience leading CQV teams and managing multiple project

s.Deep understanding of GMP regulations, validation lifecycle approach (V-model), and risk-based validatio

n.Excellent communication, organizational, and stakeholder management skill

s.Strong technical writing and documentation skill

s.Ability to work in a fast-paced, matrixed environmen

t.PMP or related project management certification is a plu

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