Role Summary:
The CQV Lead is responsible for managing and executing all activities related to Commissioning, Qualification, and Validation for projects within the organization. The role ensures that facilities, utilities, equipment, and processes are commissioned, qualified, and validated in compliance with regulatory standards (e.g., cGMP, FDA, EMA) and project requirements. The CQV Lead acts as the point of contact for all CQV matters, managing timelines, budgets, resources, and stakeholder communications.
Key Responsibilities:
Develop and lead the execution of CQV strategies and master plans for new and existing facilities, utilities, and manufacturing processes.
Oversee the preparation and approval of CQV documentation including protocols (SAT, FAT, IQ, OQ, PQ), reports, and risk assessments.
Manage commissioning and qualification execution in alignment with project schedules and budgets.
Coordinate with multidisciplinary teams (engineering, construction, automation, quality, operations, vendors) to ensure alignment of CQV activities.
Review and approve CQV deliverables and ensure they meet regulatory, internal, and client requirements.
Identify and resolve issues, deviations, and non-conformances related to commissioning, qualification, and validation.
Lead or participate in project meetings, risk assessments, and design reviews.
Develop and deliver training related to CQV processes and protocols.
Provide technical guidance and mentorship to junior CQV engineers and specialists.
Maintain up-to-date knowledge of regulatory developments and industry best practices.
Support project handover and close-out, including compiling all necessary CQV documentation for audit readiness.
Qualifications & Experience:
Bachelor’s or higher degree in Engineering, Life Sciences, or related field.
7+ years of experience in CQV, commissioning, qualification, or validation within regulated industries (e.g., pharmaceuticals, biotechnology)
Demonstrated experience in leading CQV teams and projects.
In-depth knowledge of relevant regulations and guidelines (e.g., FDA, EMA, ISPE, ASTM E2500).
Strong organizational, communication, and leadership skills.
Ability to work in a fast-paced, team-oriented environment and manage multiple priorities.
Experience with project management tools and validation lifecycle documentation.
Proficiency in MS Office Suite; experience with CQV software/tools advantageous.
Ability and willingness to travel and remain on-site as required by project.
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