Boris Gendelman P.Eng

Profile

Accomplished Mechanical Engineer (P.Eng.) experienced in Automation, Manufacturing, Project Management, in various industries (Pharma & Medical devices manufacturing, Food and Consumer Packaged Goods, Clean Room Fabrication / Electronic Assembly and Packaging, Aerospace and custom CNC Machine Tools and Lines fabrication (for automotive clients mostly)

Areas of expertise:

Capital projects associated with technology transfer, new product introduction/ commercialization, process automation, manufacturing equipment modification/upgrades

Extensive experience in vacuum, plasma, gas/chemical delivery, process instrumentation and control systems (PLC: Allen Bradley, Mitsubishi). Hands–on troubleshooting skills in wide range of process equipment, sometimes down to component (not PCB) level. 442A Electrician License

Design of Engineering experiments (DoE), SPC analysis to target KPI and capability index (Cpk) improvements (Minitab, Excel). Root cause analysis (8D methodology, PFMEA) and equipment reliability improvements. SPC based predictive maintenance (SAP, DataStream)

Professional Experience:

2022- Present Markin Professional Engineering Consulting Services

2019- 2022 Contract Pharmaceutical Ltd. (liquids & semisolids Rx & OTC)

Position: Project Engineer/ Manager

Activities:

New products and technology transfer & Integration of new business into manufacturing capabilities of the company from initial business win to validation and commercial production. Equipment commissioning, qualification, validation. Projects scope and timeline development.

RFP and RFQ generation for OEM vendors. Developing URS and FRS. Follow up on delivery schedule and initial line trials. FAT’s and SAT’s.

Accomplishments:

Project lead for nasal spray technology transfer from Europe to Canada. New equipment selection procurement, commission, start up, production turn over.

Swiss customer was under time constraint. Proposed, purchased, FATed, SATed equipment for temporary packaging solution to continue registration batch activities to avoid shortage of supply (SoS) reporting to FDA. Product is oxygen sensitive and requires modified atmosphere (MAP) filling and packaging. Currently in commercial run stage.

Saved $112k USD and 3 months lead time for Japanese customer by redesigning and fabricating locally special tooling to fill semisolid product.

Mapped airflow in the liquid filler booth to prove flammability and particulate level (ISO class 5) compliance for new product with high alcohol content. Redesigned Exhaust System for compliance with NFPA

Designed process and tooling for hand sanitizer production on semisolid filler in the beginning of Covid-19 pandemic.

Authored project plan and obtained approvals for flammable, controlled substance storage vault in compliance with Health Canada Directive, NFPA, OSHA and local Fire Department.

2017-2019 PLZ Aero Science Corp. (Aerosol Packaging Health & Personal care)

Position: Capital Project Manager/ Engineer for three (3) manufacturing sites & storage facility (flammables) in Toronto, GMP environment

Activities:

Capital projects management (engineering and financial) from inception to completion ($0.5-$5mln range) related to manufacturing lines automation, HVAC & hydro, Fire Suppression Systems (NFPA and OBC compliance) for manufacturing and flammables storage.

Accomplishments:

Identified refurbishment expert and installed 16 head filler for Class 1A flammable solvents fully NEC/ CEC compliant. Line throughput increased 9.7%. Labor cost saving of $181,470 achieved due to automation of marble dropping operation.

Oversaw two spill containment systems built. Major error in engineering calculation identified and corrected during tender stage.

Managed completion of storm water drain construction to comply with City of Vaughan master plan.

Initiated RFI, RFQs, assessed bids, authorised payments.

Researched and redesigned make up air for mixing tanks extraction systems in batch compounding area to comply with NFPA 30B and ASHRAE TLV levels for Methyl Chloride and Toluene. Selected most reliable HVAC contractor (budget saving of $38,000)

Re-engineered and personally rebuilt Propellant Gas Filling station for R&D Lab to comply with NFPA requirements. Resulted in $63,000 budget savings.

2016 Fiera Foods Inc., Toronto, ON (Commercial bakery, 5 plants, 1000+ employees)

1 year contract

Position: Project Engineer/ Manager

Activities:

Capital projects related to automation and packaging lines efficiency improvement.

New product introduction engineering support, equipment modification, upgrade, procurement

Accomplishments:

Automation for coarse sugar application and waste recovery process.

Improvement for Nutella spread task for brownies production.

Special Custom Nozzles design for éclair shells for Costco USA.

2015 GlaxoSmithKline Inc. Mississauga ON. (Pharma manufacturing liquid and semi solid dose)

1 year contract

Position: Process/Equipment Reliability Engineer

Activities:

Engineering support for liquids and semisolids primary filling and secondary packaging lines (fillers, bottle cleaners, crimpers, cappers, labelers, case packers, vision & weight inspection systems.

Nasal spray (Flonase) line ramp up to 24x7 schedule when product converted from Rx to OTC. No major capital investment.

Accomplishments:

Established line performance metrics. Identified unscheduled downtime trends and proposed feasible and effective solution utilizing internal resources. Changeover time reduced by 15min per shift. As by-product, ergonomic complaint issue was eliminated.

Proposed product waste reduction solution (due to foaming).

2010 - 2014 Apotex Inc. Toronto, ON (Pharmaceutical manufacturing liquid sterile & solid dose)

Position: Equipment and Critical facilities Qualification Engineer

Equipment & Critical Facilities commissioning, qualification. Change Control Process ownership.

Activities:

Authoring, execution IQ, OQ, PQ protocols for equipment and critical facilities. (Primary Fillers sterile and nonsterile, Isolators, CIP skids, autoclaves, granulators, Packaging Lines, Tanks and Mixers. HVAC-BAS, purified water, compressed air, nitrogen.

Development, review of design and commissioning documents (FAT, SAT, URS, FRS, criticality assessments)

Environmental monitoring for GMP regulatory compliance (stability chambers, cold storage spaces, controlled substance vaults, clean room Grade A and B sterile manufacturing)

Accomplishments:

Promptly developed and lead approval and execution IQ and OQ activities for legacy sterile filling lines (IMA) flagged during FDA audit.

Conducted environmental monitoring (temperature & humidity), analysed noncompliance events and proposed feasible engineering solutions for improvement of HVAC in Commercial Lab (controlled temp), Capsule Storage Warehouse and Controlled Substance Vault (controlled temp and humidity).

Analysed preventive and corrective maintenance data (SAP) for powder transfer and particle separation equipment. Generated report, presented to management team. MTBF improved average 12% for older and 19% for newer units.

2008 - 2010 Sony DADC Canada

Position: Process/Equipment Reliability Engineer

Activities:

Standardization of manufacturing processes to improve yield and uptime (MTBF) of injection molding clusters and electroplating equipment. Implementation and monitoring of preventive maintenance (PM) program. Supervised Maintenance team in 24/7 and 24/5 schedule.

Workload optimization through machine failures statistical data analysis.

Accomplishments:

Developed early warning system for desiccant dew point deterioration for Motan industrial dryer systems. Trained maintenance team on troubleshooting technique. Wrote SOP.

Rebuilt and maintained electroplating work center, including waste solution disposal management

Managed hands-on “resurrection” project for Sony DVD replication machine from “deep down” state to design specifications. Even senior management gave up on this machine at some point. Daily volume increased 14%.

Established chemical analysis for electroplating baths and stampers electrical quality checks to meet Sony Red Book standards. Introduced and validated new cleaning process for made ‘in house” stampers. Personally repaired vendor unsupported inspection system. Yield improved 5.7%.

B.Sc. Mechanical Engineering

Moscow State Technological University STANKIN

M.Sc. Electrical Engineering (Industrial Electronics)

Moscow University of Radio Engineering, Electronic & Automation (MIREA)

Additional training

Standard First Aid & CPR-C 2021

GMP: current trends & updates, data integrity 2020

PLC programming, integration GBC, Toronto 2015

Humidity Theory and Best Measurement Practices

GMP: Strategies for Mapping and Environmental Monitoring Vaisala 2011

Pharmaceutical Manufacturing Methods, Contamination Control Seneca 2010

Building Automation System (BAS) Siemens 2009

Financial Accounting; Law and Business Administration CGA, Ontario 2002

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