The Principal 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 project milestones are met.
- Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
- Management of Contractors and Vendors, document control, punch list management.
- Participate in design, constructability, and commissionability reviews to ensure technical aspects are covered in the Commissioning Plan and schedule.
- Well versed with risk-based approaches to C&Q (e.g., ASTM E2500, ISPE)
- Conduct risk assessments and gap analysis for process equipments/ systems, facilities and utilities, to identify critical process parameters and control strategies.
- Developing system boundaries for the system at an early stage of C&Q.
- Complete the development, review and execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports.
- Experienced in commissioning and qualifying CIP & SIP systems.
- Participate in design document reviews and ensure that quality aspects are included in design.
- Review vendor documents (CTOPs/ VTOPs) to support commissioning and qualification requirements.
- Ensures C&Q 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.
- Perform shakedown during commissioning and qualification of systems on site.
Working Conditions:
- The position may require travel and/ or deputation to other sites or manufacturing facilities.
- Ability to work in a cleanroom environment and adhere to gowning requirements.
- Flexibility to work outside of regular business hours as needed to support project timelines
