CQV Engineer

Responsibilities: Execute commissioning, qualification, requalification, and validation activities for facilities, utilities, process equipment, laboratory equipment, and manufacturing systems. Manage multiple CQV projects simultaneously, ensuring project timelines, deliverables, and compliance requirements are met. Author, review, execute, and approve IQ/OQ/PQ protocols, qualification reports, risk assessments, and supporting documentation. Support qualification of laboratory equipment and systems used in pharmaceutical testing and stability programs, including controlled temperature units and stability chambers, where applicable. Develop and support qualification strategies for facilities, utilities, controlled environments, and critical pharmaceutical manufacturing and laboratory systems. Lead or support deviation investigations, root cause analysis, CAPAs, corrective actions, and remediation activities related to CQV. Partner with Quality, Laboratory Operations, Engineering, and other stakeholders to resolve technical and compliance issues. Support equipment installations, relocations, facility upgrades, and laboratory or manufacturing improvement projects. Contribute to change controls, SOP revisions, FMEAs, periodic reviews, and validation master plans. Communicate project status, technical decisions, risks, and deliverables to cross-functional stakeholders. Support internal and external audits and regulatory inspection readiness.