Yash Patil
Mississauga,Canada
Summary
Biopharmaceutical Technologist with over a decade of expertise in aseptic manufacturing and vaccine production. Skilled in quality control, cleanroom operations, and equipment validation, ensuring strict compliance with cGMP standards. Adept at planning, environmental monitoring, and optimizing operational efficiency to uphold product integrity and regulatory requirements.
Overview
11
11
years of professional experience
Work History
Technical Group Leader, B100 MBWS Operations
Sanofi Pasteur
Toronto
03.2024 - Current
- Oversaw and managed work schedules for staff involved in media, buffer, washing, and sterilizing areas.
- Facilitate daily meetings, track progress, and report performance metrics to management.
- Ensure documents comply with GMP regulations.
- File quality notifications, lead investigations on deviations, and oversee corrective and preventive actions (CAPA).
- Oversee maintenance, validation, and certification of equipment used in media and buffer preparation, as well as washing and sterilization processes.
- Monitor and manage process orders using systems such as SAP/iShift, ensuring accurate and timely data entry.
- Work closely with internal departments (such as upstream and downstream production) and support functions (maintenance, quality control) to ensure seamless operations.
- Align production priorities, share technical expertise, and troubleshoot process issues collaboratively.
- Champion HSE (Health, Safety, and Environment) standards by ensuring proper PPE usage and adherence to safety protocols.
- Conduct routine safety inspections, and enforce proper chemical handling and storage procedures.
- Guide technical staff on formulation calculations, cleaning standards, and utility sampling procedures.
- Analyze production data to identify trends and areas for improvement; lead process improvement projects, and apply Lean/5S methodologies.
Technologist, B100 MBWS CQV/OPs
Sanofi Pasteur Ltd.
07.2022 - 03.2024
- Orchestrated scheduled operations in the Media, Washing, and Sterilization areas to maintain continuous production support.
- Executed CIP (Clean-In-Place) and SIP (Sterilize-In-Place) procedures, and performed routine maintenance on production equipment, ensuring optimal operational efficiency.
- Monitored building utilities and collaborated with the Water System Team to guarantee that all systems were fully operational for production use.
- Supervised facility monitoring to uphold prescribed environmental conditions in both production and storage areas.
- Developed and delivered comprehensive training sessions, conducted validation runs, and established standardized production procedures.
- Liaised with Upstream, Downstream, Adsorption, and other departments to ensure the timely completion of production support activities.
- Led commissioning and qualification efforts for systems in the B100 production area, ensuring readiness and compliance with regulatory standards.
- Operated critical equipment, including parts washers, tank wash stations, autoclaves, and control systems (MES, DeltaV, PI Historian), to support efficient manufacturing processes.
- Supervised the precise formulation of media and buffers at varying scales to meet dynamic production demands.
- Managed inventory, conducted regular stock assessments, and coordinated ordering processes to maintain optimal supply levels.
Technologist, QC Raw Materials
Sanofi Pasteur Ltd.
11.2019 - 07.2022
- Reviewed incoming shipments and associated documentation to ensure that raw materials met quality, integrity, and compliance standards with established specifications.
- Performed aseptic sampling of raw materials in a Grade C cleanroom, adhering strictly to SOPs, to preserve sample integrity.
- Conducted routine environmental monitoring sampling on schedule to ensure compliance with regulatory and internal quality standards.
- Operated MODA, MASTER, Phenix, GEODE+, Gibraltar systems, and MetOne units for comprehensive raw material testing and analysis.
- Executed routine cleaning of the cleanroom facility per prescribed schedules and SOPs to maintain sterility in the sampling lab.
- Verified, sampled, and tested primary and secondary packaging materials to ensure they met quality and compliance criteria.
- Utilized S4/HANA for warehouse monitoring, PO management, sample declaration, stock overview, and inventory management to support efficient quality control processes.
Sr. Lab Support Technician, W & S: Viral Vaccines
Sanofi Pasteur Ltd.
12.2017 - 12.2019
- Performed and monitored viral washing and sterilizing activities in production areas B71 and B92, ensuring adherence to strict biosafety protocols.
- Executed both automatic and manual washing procedures for upstream and downstream apparatus, optimizing equipment cleanliness and process efficiency.
- Operated autoclaves, bottle washers, and tank wash stations to maintain rigorous production equipment sanitation standards.
- Conducted decontamination of biohazardous equipment, and managed the disposal of biohazardous waste in compliance with regulatory guidelines.
- Collected and transferred periodic cleaning validation samples, supporting continuous quality verification processes.
- Prepared materials, equipment, and chemicals for safe intra-departmental transport, ensuring a seamless operational workflow.
Packaging Technician, Filling & Packaging
Sanofi Pasteur Ltd.
07.2014 - 12.2017
- Adhered to departmental SOPs and procedures to maintain cGMP standards.
- Verified labels and components according to BPR guidelines, and performed SAP transactions.
- Operated labeling, packaging, and examining lines; identified and reported defects promptly.
- Executed pre- and post-line clearance activities following the 3 'Cs' (Clean, Clear, Confirm).
- Manually inspected vials for defined defects, and categorized findings per SOP.
- Conducted sampling procedures as defined in the BPR to ensure product quality.
- Recorded line downtimes, and prepared performance assessments for continuous improvement.
- Transported materials between the warehouse, non-classified areas, and classified areas, following established SOPs and safe material flow protocols.
Education
Associate of Applied Science - Industrial Biotechnology
Centennial College
Canada12-2010
Master of Science - Bioinformatics
South Gujarat University
India04-2008
Bachelor of Science - Medical Technology
South Gujarat University
India05-2004
Skills
- GMP compliance
- Process improvement
- Team leadership
- Safety protocols
- Technical training
- Collaboration skills
- Effective communication
- Inventory management
Timeline
Technical Group Leader, B100 MBWS Operations
Sanofi Pasteur
03.2024 - Current
Technologist, B100 MBWS CQV/OPs
Sanofi Pasteur Ltd.
07.2022 - 03.2024
Technologist, QC Raw Materials
Sanofi Pasteur Ltd.
11.2019 - 07.2022
Sr. Lab Support Technician, W & S: Viral Vaccines
Sanofi Pasteur Ltd.
12.2017 - 12.2019
Packaging Technician, Filling & Packaging
Sanofi Pasteur Ltd.
07.2014 - 12.2017
Associate of Applied Science - Industrial Biotechnology
Centennial College
Master of Science - Bioinformatics
South Gujarat University
Bachelor of Science - Medical Technology
South Gujarat University
Similar Profiles
LANITRA WILLIAMSLANITRA WILLIAMS
Cart Transfer at Sanofi Pasteur (Manpower)Cart Transfer at Sanofi Pasteur (Manpower)
Ania BlountAnia Blount
Production Technician at Sanofi PasteurProduction Technician at Sanofi Pasteur
Curtis SahadathCurtis Sahadath
Contractor at Manych Mechanical Inc. - Sanofi PasteurContractor at Manych Mechanical Inc. - Sanofi Pasteur
Aseel KhalafAseel Khalaf
Production Manager at Sanofi PasteurProduction Manager at Sanofi Pasteur
Randeep KaurRandeep Kaur
Personal Support Worker at Caressent HomePersonal Support Worker at Caressent Home