PBE Expert Inc, we Process, Build, Engineer
PBE expert Inc
Employees
Director Engineering and Validation
François Goupil
Process and chemical engineer with a Bachelor from University Laval in Quebec City.
Mr François Goupil has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems CSV (cGMP, GAMP5, CFR-21 part 210, 211, 11).
Experiences
- 2010: Project Manager, MYLAN (Confab), St-Hubert, QC.
- 2009: Project Engineer, Independent worker, St-Bruno, QC.
- 2006: Senior Process & Systems Engineer, VALIDAPRO BIOSCIENCES, Laval.
- 2005: Senior Process Engineer, GENIVAR, Montreal.
- 2001: Process Engineer, Independent worker, St-Bruno.
- 2001: Project Manager, INOX-TECH Canada inc., Ste-Catherine.
- 2000: Technical Sales, AQUARIUS services & technologies inc., St-Laurent.
- 1999: Clerk, Mécanique M.G., Levis.
- 1997: Polymers and Food Chemistry Research Assistant, Laval University, Ste-Foy.
- 1996: Assistant teacher for computer assisted design and drafting, Sherbrooke.
- 1996: Plasma Physics Research Assistant, Sherbrooke University, Sherbrooke.
- 1993: Biotechnology & Environmental Technician, CREALAB inc., Rock-Forest.
- 1993: Technician (COOP), Daishowa inc.
Expertise & Skills
- Sanitary design.
- Process engineering (ASME-BPE).
- Technology Transfer.
- Layouts development.
- Cleanroom design & HVAC.
- Construction Project Management (EPCMV).
- GMP regulatory compliance audit.
- Commissioning, FAT, SAT.
- Equipment Qualification IQ, OQ, PQ.
- Process Validation and Cleaning.
- CSV, Validation Informatique.
- Integrity and data collection IT & Audit.
- Data serialization and standardization.
- Calibration & Metrology.
- Maintenance.
- Warehouse mapping & Fridge.
- Quality Assurance & ISO 9001 Certification.
- Pre-Inspection Audit (PAI).
- Training.
Bureau
CANADA
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