Senior CQV Engineer - 175006

Responsibilities: Execute commissioning, qualification, requalification, and validation activities for facilities, utilities, equipment, and manufacturing systems. Lead and manage multiple CQV projects simultaneously, ensuring timelines, deliverables, and compliance requirements are met. Author, review, execute, and approve CQV protocols, reports, risk assessments, and supporting documentation. Develop and support qualification strategies for cleanrooms, controlled environments, utilities, process equipment, and manufacturing systems. Drive investigations, deviations, CAPAs, corrective actions, and remediation efforts from a CQV perspective. Partner with Quality and cross-functional stakeholders to resolve complex technical and compliance issues. Support equipment relocations, facility upgrades, and manufacturing expansion projects. Participate in smoke studies, airflow visualization studies, environmental qualification activities, and cleanroom validation efforts. Contribute to change controls, SOP revisions, FMEAs, periodic reviews, and validation master plans. Provide technical guidance and mentorship to junior CQV team members. Support internal and external audit preparation and inspection-readiness initiatives. Clearly communicate technical decisions, project status, risks, and deliverables to cross-functional stakeholders.