Boris — Project Engineer

2019- 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 through validation to 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 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 reporting to FDA. Product is oxygen sensitive and requires modified atmosphere (MAP) filling and packaging. Currently in final pre commercial run stages. Saved $112k USD and 3 months for Japanese customer by redesigning and fabricating locally special tooling to fill semisolid product. Mapped airflow in the liquid filler booth ISO class 5 to prove flammability compliance for new product with high alcohol content. Redesigned Exhaust System. Designed process and tooling for hand sanitizer production on semisolid filler in the beginning of Covid-19 pandemic. Analyzed and designed project plan and obtain approvals for flammable, controlled substance storage vault in compliance with Health Canada Directive, NFPA, OSHA and local Fire Department

(Aerosol Packaging Health & Personal care) Position: Capital Project Manager/ Engineer for three (3) manufacturing sites & storage facility 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, and evaluated bids. Authorised payments. Researched 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 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.

Toronto, ON (Commercial bakery, 5 plants, 1000+ employees) 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.

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. Flonase line ramp up to 24x7 schedule when 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).

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%.

(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% 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