Expert Details

Expert in Pharmaceutics

Expert ID: 734912 Canada

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Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21 part 210, 211, 11).

Moreover, Expert's CSV validation documents have successfully passed a general inspection without any observations from the FDA. Specific software or system: Network Infrastructure, JD Edwards ERP, Empower chromatographic data, building monitoring system, data historian.

Expertise & Skills include:
- Sanitary design
- Process engineering
- Technology transfer
- Layouts development
- Cleanroom and HVAC Design
- Construction & project management
- GMP regulatory compliance audit
- commissioning, FAT, SAT
- Equipment qualification (IQ, OQ, PQ)
- Cleaning processes validation
- CSV, computer system validation
- IT integrity and data collection & audit
- Data serialization and standardization
- Calibration and metrology
- Maintenance
- Warehouse & fridge mapping
- Quality Assurance & ISO 9001 Certification
- Pre-inspection audit
- Training

Education

Year Degree Subject Institution
Year: 1999 Degree: B.Sc. Subject: Chemical Engineering Institution: Laval University
Year: 1993 Degree: Technician Subject: Chemical Engineering Institution: Levis-Lauzon College

Work History

Years Employer Title Department Responsibilities
Years: 2017 to Present Employer: Undisclosed Title: Director Engineering and Validation Department: Responsibilities: Prepare the technical specifications, layouts, process descriptions and other specialized
documentation. Write the specifications for production equipment. Develop the detailed engineering.
• Mass and energy balances
• Process flow diagrams (PFD).
• User requirements specifications (URS).
• Process and instrumentation diagrams (P&ID).
• Classification charts and room zoning
• Equipment and clean utilities matrix.
• Development of traceability matrix and of protocols of design qualification (DQ)

Write production equipment specifications.
Develop functional analysis and ensure their implementation.
GANT and project management diagrams creation.
Develop detailed engineering.
Provide technical support and commisioning expertise.
Follow up with customers, suppliers and subcontractors.
Analyze submissions and write letters of recommendation.
Write the cleaning and process validation protocols.
Perform equipment, clean utilities and systems qualification and validation.
Years: 2010 to 2017 Employer: MYLAN (Confab) Title: Project Manager Department: Responsibilities: Redaction of engineering document: specifications, user requirements, factory acceptance test, design qualification.
Redaction of validation documents: validation master plan, installation and operation qualification, process and packaging validation, cleaning validation, computer validation.
Project management: plans, RACI, Gantt charts, meetings, communication.
Project execution: Design review, subcontractor management, and financial follow-up.

Project management for the implantation of equipment’s for production and packaging of ointments:
Denavir, desoxymethasone, mesalamine.

Construction of a new unit dedicated to Medical and supplement soft chew (gummy) products.
JD EDWARDS (ORACLE)
Computer system validation of the complete ERP package. Includes validation plan, risk analysis,
function classification in low, medium and high impact, redaction of unit and integrated tests.
Infrastructure qualification, backup, audit trails, archiving, SOP for systems, Operational qualification
and Performance Qualification.

Computer system validation of the complete empower server package. Includes validation plan, risk
analysis, function classification in low, medium and high impact, redaction of unit and integrated tests.
Infrastructure qualification, backup, archiving, audit trails, SOP for systems, Operational qualification and Performance Qualification. Also includes user access strategy and verification.

▪ Manage and implement equipment projects for creams, ointments, suppositories, gels, tablets, capsules, HVAC systems, purified water & compressed air.
▪ Redaction of quotes, URS, functional specifications & FAT/SAT.
▪ Plan, organize and integrate projects.
▪ Write maintenance plans, training & procedures.
▪ Manage design, professional teams & subcontractors.
▪ Carry out capital applications & profitability studies.
▪ Financial monitoring of projects.
▪ Manage and qualify equipment manufacturing projects for tablets, capsules, suppositories, cardboard, HVAC & purified water.
▪ Write computer validation protocols and perform software qualification.
▪ Write validation protocols and perform the qualification of equipments & systems.
▪ Write process validation protocols and carry out studies.
▪ Review production master files.
▪ Review change controls.
▪ Write annual product reviews.
Years: 2006 to 2008 Employer: VALIDAPRO Title: Senior Process & Systems Engineer Department: Responsibilities: Conceptual study for the construction of a new building dedicated to FDA products.

Installation qualification protocols for the clean rooms and access card system.

Installation and operational qualifications execution for high potent vial production building and for solid
oral dosage building.

Project services for the construction of the facility. Selection and bid analysis for the purified water
system, washer and sterilization.

Design review of the bid packages and specifications.

Basis of design for the pharmacy at the hospital. Design review of the bid packages.

Pilot plant freeze-dryer specifications and bid analysis.

Nicotine hard candy line specifications and bid analysis.

For the production of sterile implantable lens, purified water system specifications and bid analysis.

Design review for the plant expansion project.

Process validation protocols for the production of speciality medical devices.

Sterile manufacturing production unit for highly potent lyophilized injectable. Building 7 modification to
systems for use with highly potent products. User requirements, functional and technical
specifications. Supply management for formulation, sterile filtration, lyophilisation, purified water, water
for injection, pure steam generator, pharmaceutical washer and clean in place.

Oral Solid dosage form production unit for highly potent and cytotoxic tablets. Construction of new
building. User requirements, functional and technical specifications. Supply management for tablet
press, granulator, biological safety hood, purified water, pharmaceutical washer, HVAC, clean rooms,
compressed air dryer.

Sterile manufacturing pilot plant line. User requirements, functional and technical specifications for
formulation tank, sterile filtration and clean in place. System analysis for purified water production and
storage.

▪ Prepare mass and energy balances, Process Flow Diagrams (PFD) and Process & Intrumentation Diagrams (P&ID).
▪ Prepare feasibility studies (factories & laboratories construction).
▪ Prepare implementation studies (production equipments).
▪ Write specifications for production equipment and utilities such as purified water systems, HVAC & clean compressed air.
▪ Complete detailed engineering.
▪ Ensure the coordination of constructions works and stakeholders on the project and on-site.
▪ Write and execute FAT, SAT & validation protocols and perform equipment, clean utilities, pharmaceutical systems and IT infrastructures (PLC, BMS, BAS, ERP) qualification according to GAMP5 and CFR-21, part-11.
▪ Manage employees and subcontractors on site.
Years: 2001 to 2006 Employer: CONFAB Title: Project Engineer Department: Responsibilities: High level management for environmental projects on contaminated soils, asbestos, petroleum product
tanks and wood pole.

Drain line relocation in production areas. Design and schematics.

Technical study of airflow and cooling load.

Pneumatic Shop laboratory ventilation and plumbing upgrades.

Pharmaceutical Research facility including chemistry labs, biology labs and animal labs. Process &
Clean Utilities evaluation for the 2006 Expansion conceptual report, specifications and drawings.

Manufacturer of seamless stainless steel tubing. Trichloroethylene elimination project. Process and
Equipment technology evaluation. Conceptual report for the new cleaning station.

Process design for the egg waste treatment system. Installation specifications for GMP autoclaves and
GMP washers. Specifications for process tanks. User requirement specifications for a CIP/SIP system.

Process vent system upgrade for manufacturing skids.

Ethyl and Propyl alcohol system upgrade study

Process optimization and validation for extrusion, molding and assembly of plastic parts for catheters.
Forane replacement project, tests and validation.

Ammonia system upgrade study.

Process engineering and system design of a carbon filter water purification system.

Design for bid of modular process equipment for the product conditioning and purification for a
pharmaceutical company producing antibody and recombinant proteins.

Design for bid of modular system for the preparation and distribution of caustic soda for a
pharmaceutical company producing antibody and recombinant proteins.

Design for bid of process piping, purified water piping, clean steam piping and CIP/SIP system for a
generic product drugs.

Design of a wastewater neutralization system using carbon dioxide and caustic soda.

Study of water usage throughout the plant. Wrote the Water management action plan for the company.

Fuel quality action process for the construction, demolition and recycled wood (CD&RW) utilized as
wood fuel at biomass power plants.

Site work, process flow sheet, process and instrumentation diagram, isometrics views, site supervision
for the installation of the filler CIP system.

Design of a scrubber unit.
Years: 2001 to 2001 Employer: INOX-TECH CANADA INC Title: Project manager Department: Responsibilities: Design for process flow sheets, P&ID and layout. Calculation for piping, pumps and heat exchangers.

Equipment lists, cost estimation and procurement. Design of liquid ingredient distribution system for 10
bakeries (water, sugar, oil, shortening, liquid yeast). Custom design of CIP units. Installation and
commissioning. Management of plant shutdown. Quality control of stainless steel fabrication.

Project management and design of a liquid ingredient system.

Yearly Shutdown, management.

Process troubleshooting.

Design of an apple juice concentrate plant.

Project management, Modification for the CIP Unit. Modification to the liquid ingredient system.

Liquid yeast distribution system design.

Project management, Site work preparation, coordination of disciplines

Process specification of temperature control for three liquid sugar tanks.

P&ID review, equipment specifications, control system revision.

Design and evaluation of a UF membrane manufacturing unit.

P&ID for liquid distribution system.

Project management, Quality control, design for a self controlled unit of glycol water for sugar tank temperature control.

Project management for the supply of 7 conveyors and 5 process tanks.

Design of a modular dairy.

Project management fabrication of 2 amine tanks.

Project management and Quality control reports for several tanks of purified water systems.

Design and specification of an heat exchanger destined to cool oil from a
hydroelectric facility.

Pumps specifications.

Process management, bill of material and site work planning.

Project management process modification and CIP updates

Prepare submissions and communicate with clients.

Prepare research and development tax credit applications.

Manage employees and subcontractors on site.
Years: 2018 to 2018 Employer: INOX-TECH CANADA INC Title: Project Manager Department: Responsibilities: On-site assistance:
▪ Engineering study.
▪ Gap Analysis.
▪ Risk Analysis.
▪ Validation master plan.
▪ Computer System Validation
Years: 2005 to 2006 Employer: WSP Title: Process Engineer Department: Responsibilities: ▪ Perform on-site records.
▪ Perform the calculations; Develop concepts.
▪ Produce plans and quotes; Estimate costs.
▪ Prepare submission documents.
▪ Prepare timeframes.
Years: 2002 to 2005 Employer: Self Employed Title: Process Engineer Department: Responsibilities: Draw process diagrams and piping & instrumentation diagrams.
▪ Perform process systems design.
▪ Write quotes for process piping, pumps, heat exchangers and valves.
Years: 2000 to 2000 Employer: AQUARIUS SERVICES & TECHNOLOGIES Title: Technical Advisor in Environment Department: Responsibilities: ▪ Process design (decantation, floculation, filtration, reverse osmosis).
▪ Provide price studies (equipment, installation).
▪ Supervise installation. ▪ Supervise sales and marketing.
Years: 1996 to 1999 Employer: UNIVERSITÉ LAVAL Title: Intern & Research Assistant Department: Responsibilities: ▪ STELA – Dairy Science and Technology Research Center.
▪ CERSIM – Center for Research and Engineering of Macromolecules. ▪ CREPE – Center for research in energy, plasma and electrochemistry.
Years: 1993 to 1995 Employer: CREALAB Title: Technician in environment and biotechnology Department: Responsibilities: ▪ Operation of silo-corridor composting project.
▪ Operation of sequential biological reactors project.
▪ Pilot tests on bio-filters.
▪ Sample preparation. ▪ Physical and chemical analyzes.

Career Accomplishments

Associations / Societies
Ordre des Ingenieurs du Quebec
ISPE
Licenses / Certifications
Quality Assurance & ISO 9001 Certification

Language Skills

Language Proficiency
French Native
English Very Good

Fields of Expertise

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