Ravi Goswami
Fuquay-Varina
Summary
Results-driven CQV Lead with extensive experience in strategic consulting and delivering solutions for complex projects. Expertise in managing large-scale CAPEX initiatives, ensuring compliance and timely execution. Proficient in stakeholder engagement, problem-solving, and client relationship management, consistently driving successful outcomes in regulated environments.
Overview
12
12
years of professional experience
1
1
Certification
Work History
CQV Consultant
Johnson & Johnson
11.2025 - Current
- Development of comprehensive project plans, ensuring timely execution and resource allocation for Black & Clean Utilities.
- Point CQV person for Vendor review for Black & Clean Utility Vendor Packages.
- Liaise with Contractor in relation to construction readiness and a schedule for Black & Clean Utility systems.
- Liaise with CQV SWAT Team in relation to punchlist closure pre-M/C and during the CQV execution phase for Black & Clean Utility systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for Black & Clean Utility systems, ensuring all correct predecessors and successors are in place
- Ensure Commissioning readiness of Black & Clean Utility systems to support Start-up and CQV Testing.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Black & Clean Utility systems are managed appropriately for the entire Project Lifecycle.
- Support execution of all Black & Clean Utilities systems CQV deliverables; FAT/SAT/CTP/IV/OV/PV
- Run Weekly Black & Clean Utility Systems Meeting and ensure updates are provided to Weekly CQV Meeting.
- Liaise with all site Building Leads to ensure all relevant CQV milestones and durations are captured and tracked in the Master Project Schedule.
Commissioning Manager
Wolfspeed
01.2024 - 08.2025
- Responsible to establish a commissioning program to be used in support of project completion.
- Leadership of the Commissioning Team in the development and implementation of the handover and commissioning strategy.
- Responsible to implement effective walk down (W1 & W2) & punch list management procedure.
- Identify and implement continuous improvement ideas to enhance the program.
- Provide leadership and oversight on commissioning activities for entire project.
- Facilitate meetings and activities with vendor project managers.
- Create and implement the commissioning strategy and procedures for the project, engaging all partners to actively support across all areas.
- Effectively communicate progress of project scope, schedule and budget, as well as update key partners and management on the commissioning process.
- Ensure excellent vendor results through oversight and performance management.
- Build relationships between on-site field commissioning engineering and operation teams.
- Ensures quality and timeliness of commissioning deliverables.
- Monitors project commissioning progress, in conjunction with the Project Manager to ensure achievement of schedule and budget targets.
CQV Lead
Fujifilm Biotechnologies
03.2022 - 12.2023
- Point CQV person for Vendor review for all Process Support Equipment Vendor Packages.
- Lead CQV PSE Team from initial design to final Handover.
- Liaise with Jacobs Engineering in relation to construction readiness and a schedule for all Process Support Equipment and Warehouse systems
- Liaise with CQV Team in relation to punch list closure both pre-M/C and during the CQV execution phase for all Process Support Equipment systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Process Support Equipment and Warehouse Systems to support Equipment Start-up and IOQ Testing.
- Lead execution of all Process Support Equipment and Warehouse systems and CQV deliverables; FAT/ SAT/IOQ.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Process Support Equipment Systems are managed appropriately for the entire Project Lifecycle.
- Run Weekly Process Support Equipment and Warehouse Meeting and ensure updates are provided to Weekly CQV Meeting.
- Liaise with all site Building Leads to ensure all relevant CQV milestones and durations are captured and tracked in the Master Project Schedule.
Project Lead
Sanofi Pasteur
01.2019 - 02.2022
- Enhanced Sterilization validation documentation through rigorous protocol generation and reporting.
- Executed Sterilization Validation protocols, ensuring compliance with industry standards.
- Led comprehensive re-qualification studies for critical sterilization equipment and processes.
- Coordinated LIMS and SAP for efficient sample management and statistical analysis.
- Resolved discrepancies by investigating root causes and implementing corrective actions.
- Provided sterilization expertise to troubleshoot processes effectively.
CQV Lead
Adaptimmune
06.2017 - 01.2019
- Ensured timely outcomes by coordinating meetings across various departments.
- Executed commissioning and validation activities across multiple project phases.
- Reviewed and prepared protocols, SOPs, and summary reports for compliance.
- Qualified process and laboratory equipment, ensuring operational excellence and safety.
- Conducted root cause analysis to resolve discrepancies and implement corrective actions.
- Led temperature mapping studies for controlled temperature units, ensuring compliance.
CQV Lead
Medimmune
03.2016 - 05.2017
- Executed utility systems including steam, lab gases, vacuum, and clean air.
- Managed upstream equipment operation, including bioreactors and media prep tanks.
- Oversaw downstream equipment processes, such as chromatography skids and buffer tanks.
- Developed and executed commissioning and qualification protocols for biopharmaceutical equipment.
- Conducted spray coverage studies for various manufacturing equipment efficiency.
- Interpreted P&IDs and controlled instrumentation for operational effectiveness.
CQV Lead
Merck & Co
02.2015 - 02.2016
- Optimized chromatography skid operations, ensuring seamless integration with utilities and isolators.
- Achieved successful equipment qualification through meticulous commissioning of biopharmaceutical systems.
- Enhanced protocol accuracy by preparing, reviewing, executing IOC & IOQ for equipment.
- Utilized P&IDs, control equipment knowledge for efficient biopharmaceutical process management.
- Resolved discrepancies by investigating root causes and implementing effective corrective actions.
Senior Validation Specialist
Janssen Biotech
03.2014 - 02.2015
- Enhanced trial execution by managing temperature monitoring for Janssen Pharma R&D.
- Approved all Investigational Site Temperature Management Equipment Questionnaires for Cold Chain.
- Provided expertise in Temperature Management requirements, ensuring compliance and efficiency.
- Prepared and reviewed sample plans, requests, and reports for temperature management campaigns.
Validation Specialist
Apicore US LLC
09.2013 - 03.2014
- Ensured compliance by executing IOQ protocols for solid dosage equipment.
- Qualified manufacturing equipment including blenders, granulators, dryers, and tablet presses.
- Identified root causes of discrepancies and implemented corrective actions effectively.
- Led cross-functional meetings and training to enhance quality improvement initiatives.
- Conducted temperature mapping studies for refrigerators and freezers, ensuring compliance.
Education
Master of Science - Pharmaceutical Manufacturing
Stevens Institute of Technology
Hoboken, NJMBA - Healthcare Management
Department of Hospital Management
Patan, IndiaBachelor - Pharmacy
B.M. Shah College of Pharmaceutical Edu & Research
Modasa, IndiaSkills
- Kneat
- EIDA
- Procore
- Facility Grid
- Cx Alloy
- Smartsheet
- Bluebeam
- Navisworks
- Primavera P6
- Power BI
- MS Office
- ProCal System
- LIMS
- SAP System
- Master Control
- truVAULT
- Trackwise
- PIMS
Certification
- Pharmaceutical Manufacturing Practices (PMP)
- Validation & Regulatory Compliances (VRC)
Timeline
CQV Consultant
Johnson & Johnson
11.2025 - Current
Commissioning Manager
Wolfspeed
01.2024 - 08.2025
CQV Lead
Fujifilm Biotechnologies
03.2022 - 12.2023
Project Lead
Sanofi Pasteur
01.2019 - 02.2022
CQV Lead
Adaptimmune
06.2017 - 01.2019
CQV Lead
Medimmune
03.2016 - 05.2017
CQV Lead
Merck & Co
02.2015 - 02.2016
Senior Validation Specialist
Janssen Biotech
03.2014 - 02.2015
Validation Specialist
Apicore US LLC
09.2013 - 03.2014
MBA - Healthcare Management
Department of Hospital Management
Bachelor - Pharmacy
B.M. Shah College of Pharmaceutical Edu & Research
Master of Science - Pharmaceutical Manufacturing
Stevens Institute of Technology