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The Sr. CQV Engineer/ CQV Lead will be responsible for leading the efforts for commissioning, qualification, and validation of equipment/ systems, and processes in the production of Drug substances/ Drug Product/ Sterile Facilities/ API/ OSDs, as well as the Utility system, HVAC system and Area.

The role will require the leadership of an experienced, energetic, and committed Senior/ Lead CQV person with broad experience in C&Q;, particularly biopharmaceuticals.

The person should have experience of leading a team of CQV engineers for a project and managing the C&Q; documentation and execution lifecycle from SLIA generation through to OQ completion. The lead will work closely with cross-functional teams, including engineering, quality assurance,



and manufacturing, to support the successful delivery of projects.

Key Responsibilities
- Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
- To prepare C&Q; plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
- Ensure all commissioning and qualification procedures are implemented and adhered to at office and at site level.
- Track progress of C&Q; activities as required and provide regular project updates and status reports to stakeholders.
- Ensure effective resource planning, including coordinating materials, spares and consumables for commissioning and qualification activities.
- Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
- Provide leadership in team meetings and facilitate problem-solving discussions to ensure

📌 Lead CQV Engineer (Kolkata Metropolitan Area)
🏢 Jacobs
📍 Kolkata Metropolitan Area