We are looking for a CQV Project Lead to take ownership of clean utilities projects across pharmaceutical and biotech manufacturing facilities. This role is focused on leading CQV delivery for clean utility systems, with responsibility for project execution, technical coordination, client communication and delivery of project scopes up to €€m.
Responsibilities
* Lead CQV activities for clean utilities projects from planning through execution and handover.
* Take ownership of project scope, schedule, resources, documentation and delivery milestones.
* Manage CQV workstreams for systems including WFI, purified water, clean steam, process gases, compressed air and CIP/SIP.
* Develop and review CQV plans, URS, risk assessments, test protocols, reports and traceability documentation.
* Lead commissioning, IQ, OQ, system walkdowns, FAT/SAT support and qualification close-out.
* Coordinate engineering, QA, validation, automation, vendors and client stakeholders.
* Manage project risks, deviations, change controls, punch lists and technical issues.
* Ensure all CQV activities are delivered in line with GMP, Annex 15, GAMP 5 and client quality expectations.
* Provide technical leadership to CQV engineers and external project teams.
* Report project progress, risks and key actions to internal leadership and client teams.
Requirements
* Strong CQV, qualification or validation experience within pharmaceutical, biotech or GMP project environments.
* Proven experience leading clean utilities projects or major CQV workstreams.
* Strong technical understanding within the area of WFI, purified water, clean steam, clean gases, compressed air and CIP/SIP systems.
* Experience managing project scope, timelines, documentation, vendors and client communication.
* Good understanding of GMP documentation, risk-based qualification and system lifecycle requirements.
* Ability to lead cross-functional project teams and drive delivery in a client-facing environment.
* Experience supporting projects from design review through commissioning, qualification and handover.
This opportunity will provide you to work on challenging high-value capital projects.
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