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The CQV Engineer will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes used in the production of Drug substances/ Drug Product/ Sterile Facilities/ API/ OSDs, as well as the Utility system, HVAC system and Area. This role ensures that all systems operate as intended and comply with regulatory standards. The CQV Engineer will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.

Key Responsibilities
- Familiarity with risk-based approaches to C&Q; (e.g., ASTM E2500, ISPE).
- Develop and execute commissioning and qualification lifecycle protocols for new and existing process equipments/ systems,



facilities and utilities.
- Prepare C&Q; plans in line with the strategic goals of the client and as per regulatory requirements.
- Experienced in commissioning and qualifying CIP & SIP systems
- Conduct risk assessments and gap analysis for process equipments/ systems, facilities and utilities, to identify critical process parameters and control strategies.
- Participate in design document reviews and ensure that quality aspects are included in design.
- Developing system boundaries for the system at an early stage of C&Q.;
- Review vendor documents (CTOP/ VTOPs) to support commissioning and qualification requirements.
- Ensure non-conformances or deviations are minimized during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
- Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews.
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📌 CQV Engineer (Ahmedabad)
🏢 Jacobs
📍 Ahmedabad