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Engineer Mechanical

Location:
Toronto, Ontario, Canada
Posted:
November 15, 2018

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Resume:

Boris Gendelman P.Eng

Profile

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

Areas of expertise:

Capital projects associated with automation, HVAC, equipment commissioning, qualification, (SAT, FAT, authoring and execution of IQ, OQ, PQ protocols),

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

Experienced in supervision and training of maintenance staff. Authoring maintenance SOP, WI.

SAP data maintenance and analysis

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, BaaN)

Working knowledge of Lean manufacturing, Six Sigma and World Class Manufacturing (WCM): Autonomous Maintenance (AM) and Professional Maintenance (PM) pillars.

Professional Experience:

2017 PLZ Aero Science Corp. (Aerosol Packaging)

Position: Capital Project Manager/ Engineer, 3 (class 1) manufacturing facilities in GTA; industrial solvents, paints, insecticides, cooking and hair sprays (GMP environment)

Activities:

Capital projects management (engineering and financial) from inception to completion ($0.5-$5mln range) related to HVAC, EHS, production lines (filling and packaging) automation, Fire Suppression Systems (NFPA and OBC compliance).

Accomplishments:

Identified refurbishment expert and installed 16 head filler for Class 1A flammable solvents fully NEC/ CEC compliant. Actual 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.

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

Personally reengineered and rebuilt Lab Gas Filling station to comply with NFPA requirements. Resulted in $63,000 budget savings.

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

Position: Project Engineer

Activities:

Engineering support for artisan bread, pastry, bagel and cookie production/packaging lines

Capital projects related to automation and line efficiency improvement

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

Accomplishments:

Installation of bagel seed applicators and recovery system;

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)

Position: Equipment Reliability Engineer

Activities:

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

Authoring and execution IQ, OQ, PQ protocols. SAP data management (equipment, maintenance, spares)

Accomplishments:

Established line performance metrics. Identified unscheduled downtime trends and proposed feasible and cost 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 and 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 non sterile, Isolators, CIP skids, autoclaves, granulators, Packaging Lines, Tanks and Mixers. HVAC-BAS, purified water, compressed air, nitrogen.

Analysis and review of Preventive and Corrective Maintenance data for equipment reliability improvements (MTBF, MTTR).

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

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

Accomplishments:

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.

Promptly developed and lead approval and execution IQ and OQ activities for legacy sterile filling lines 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).

2008 - 2010 Sony DADC Canada (injection molding fully automated manufacturing clusters, CPG)

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. Work load optimization through machine failures statistical data analysis.

Accomplishments:

Established and maintained half disc database, conducted statistical analysis for process capability. Yield improved 7.2%. Trained technicians and operators.

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

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

Established chemical analysis of 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%.

Designed and managed HVAC upgrade project for lower viscosity less hazardous resin replacement. No reduction in yield and uptime.

2003 -2008 Gennum Corporation (Semiconductor manufacturing, Electronic Assembly, Medical Devices) Burlington, ON

Position: Process/Equipment Reliability Engineer

Activities:

Ownership of Print & Fire/High Density Interconnect (HDI) and Hybrid encapsulation work centres for multichip module (MCM) hybrid circuit manufacturing on ceramic substrates and PCB’s,

SPC charts analysis, production documentation support (ECNs, TSD, NCRs), New Product Introduction (NPI) and transfer to production.

Product traceability, serialization and error proofing. Root cause analysis (8D methodology, CAPA system), PFMEA. Authoring PHSRs.

Accomplishments:

Conducted product light sensitivity study, qualified and implemented process change, resulted in product recovery of $98,000US per annum. Before the change it was scrapped.

Performed SPC analysis of device encapsulation process. Generated report and presented to management team. Implemented recommendations resulted in 10% scrap reduction.

Eliminated ergonomically unfriendly process step. JHSC initiative. Developed and validated machine design concept. Throughput increased 32%. Operators gratitude-priceless.

Installed equipment and facilities for new product line on 15 percent less than projected budget. Capital savings of $30,000

Redesigned critical spare part and identified alternative North American supplier. Lead time reduced to next day delivery instead of two weeks. Parts were previously shipped from Germany. Cost reduced 6 times.

Designed and build uninterruptible chemical supply system for dispensing machine. Resulted in material cost saving of $20,000 annually

B.Sc. Mechanical Engineering

Moscow State Technological University STANKIN, Moscow, Russia

M.Sc. Electrical Engineering (Industrial Electronics)

Moscow University of Radio-Electronic & Automation (MIREA)

Additional training

GMP: current trends and updates, data integrity 2015

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) for Sony Canada Siemens 2009

Statistical process control and DoE U of T 2007

Financial Accounting; Law and Business Administration in Canada CGA, Ontario 2004

Developing & Managing Preventive Maintenance Program. AMI 2004

Lean Manufacturing Techniques, PFMEA, Six Sigma improvement projects 2003



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