Role Summary:The CQV Lead will take overall responsibility for all commissioning, qualification, and validation activities associated with both upstream and downstream manufacturing processes at the facility. This includes cell culture/fermentation (upstream) and purification/separation (downstream) equipment and systems. The role is key to ensuring GMP compliance and successful project delivery, coordinating multidisciplinary project teams, and acting as primary CQV point of contact throughout the project lifecycle.Key ResponsibilitiesDevelop and manage comprehensive CQV plans for upstream and downstream processing equipment (including bioreactors, fermenters, filtration, chromatography skids, centrifuges, dryers, etc.) and supporting utilities.Oversee preparation, review, and approval of CQV documentation, including URS, DQ, IQ, OQ, PQ protocols and summary reports.Lead and execute commissioning and qualification activities: witnessing FAT/SAT, managing start-up and troubleshooting, and ensuring timely closure of punch-list items.Direct execution of process validation activities, including media fills, process simulations, cleaning validation, and performance qualification for critical unit operations.Ensure project deliverables meet internal quality standards and regulatory requirements (cGMP, FDA, EMA, ICH Q7/Q9/Q10, EU Annex 1).Coordinate activities and resources across engineering, automation, QA/QC, manufacturing, and third-party vendors.Manage the resolution of deviations, changes, CAPAs, and ensure robust investigation and documentation.Conduct risk assessments and lead the team in systematic review and mitigation planning for new equipment/processes.Facilitate project meetings, progress reviews, and provide regular status updates to senior management and stakeholders.Train and mentor CQV engineers and junior team members on best practices and project-specific requirements.Support regulatory and client audits, ensuring documentation and processes are audit-ready.Skills & Experience RequiredBachelor's or Master's degree in Engineering, Life Sciences, or a related discipline.Minimum (10) years CQV experience in biopharmaceutical, pharmaceutical, or chemical manufacturing, with direct hands-on experience in both upstream and downstream process environments.Demonstrated leadership experience in managing large-scale CQV projects, including scheduling, resource management, and team coordination.Deep understanding of upstream processing (cell culture, fermentation) and downstream processing (filtration, chromatography, centrifugation, drying, etc.) and associated GMP/validation requirements.Proven track record with CQV documentation lifecycle management and execution.Strong problem-solving, conflict resolution, organization, and communication skills.Familiarity with process automation, utility systems, and integration of process controls in a GMP environment.Experience managing and responding to regulatory inspections and audits.