PBE Expert Inc, we Process, Build, Engineer
PBE expert Inc
Employees
Process and chemical engineer with a Bachelor degree from Sherbrooke University and Master level courses in Engineering, concentration in International project management and global engineering. Mrs Lestage has more than 15 years experience in engineering, QPIC, research and development, batch release, SOP, processes & cleaning validation, validation of cleaning and processes, Lean manufacturing & Green Belt & technical transfers (cGMP, CFR-21 part 210).
Experiences
- 2018 : Director of Projects, PBE, Laval, QC.
- 2016 : Engineering consultant, Independant, Chateauguay.
- 2013 : Senior Process and Technical Transfert Engineer, Level II, Confab, St-Hubert.
- 2005 : Senior Validation and Technical Transfert Engineer, Valeant, Ville St-Laurent.
- 2004 : Microsoft Access Programmer, Ramonage Express/Men in Black, St-Edouard.
- 2003 : Junior Process Engineer, Thona Canada ULC, Magog.
- 2001 : Junior Quality Engineer, H Power Enterprise Canada ULC, Magog.
- 2000 : Microsoft Access Programmer – Research Assistant, Sherbooke University.
- 1999 : Chemical Engineer Internship, SNC-Lavalin Environment, Longueuil.
- 1998 : Chemical Engineer Internship, Ultramar Refinery, St-Romuald.
Lean manufacturing & Green Belt
- Brainstorming, Kanban, Pareto, 6 Sigma, Lean, 5S, Capability index Process Capability.
- Design of Experiment, 5 Whys, FMEA, Risk Management, Graphical Analysis Charts.
- Process Mapping (Ishikawa), Sampling / Data, Statistical Analysis, Value Stream Mapping.
- Elimination of Residual Solvent Testing by Mathematical Proofing on many solid pharmaceutical finished product – Won the “Most innovative Project Award” (cost reduction in 2006 of 260 000 US$ in testing).
Profile
His quality experiences include numerous lot releases, the writing and review of CAPA and SOP, FDA and Health Canada audits, and numerous responses to inspection observations.
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.
- Maintenance.
- Data serialization and standardization.
- Warehouse mapping & Fridge.
- Quality Assurance & ISO 9001 Certification.
- Release of Lots.
- Pre-Inspection Audit (PAI).
- Training.
Bureau
CANADA
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