We are seeking an experienced CQ Manager to lead Commissioning & Qualification (CQ) activities across facilities, utilities, and process equipment for a Respiratory drug manufacturing facility. The scope includes infrastructure, equipment and all supporting utility systems within a GMP-regulated environment.
Key Responsibilities:
* Serve as the overall CQ lead across utilities, facility systems, and manufacturing equipment, including filling lines.
* Oversee planning, coordination, and execution of CQV lifecycle activities, from design review through IOQ.
* Develop and manage the CQ strategy in alignment with project timelines and regulatory requirements.
* Coordinate with internal departments (QA, Engineering, Validation, Manufacturing) and external contractors/vendors.
* Ensure alignment with site standards and leverage existing methodologies where applicable (e.g. SAT to IOQ leveraging).
* Lead or support risk assessments, schedule management, and issue resolution.
* Provide oversight of documentation (protocols, reports) and ensure timely execution and closure.
Required Experience & Skills:
* 8+ years of experience in CQV within pharmaceutical/biotech manufacturing.
* Strong background in utilities (e.g., WFI, clean steam, HVAC, compressed air) and facility systems.
* Proven experience with filling lines and process equipment within a GMP environment.
* Familiar with Respiratory drug manufacturing processes and associated compliance requirements.
* Strong leadership and coordination skills across multidisciplinary teams.
* Experience working on large-scale CAPEX projects preferred.
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