David Kukelko Email & Phone Number

Winnipeg, Mb, Ca

Winnipeg, Manitoba, Canada

-Tech transfer, scale-up, in-house and CMO-Process assessment, facility fit-Generation of protocols, execution, reporting-Risk management (FMEA, HAZOP, HAACP, PHA)-Site Global Serialization Project Lead-Process transfer and materials for RTU Isolator

Winnipeg, Canada Area

-Generation of protocols, execution, reporting-Tech transfer, scale-up-Process assessment and design-Supplier quality management

Winnipeg, Canada Area

-Project plans, URS, assessments.-Procurement, installation and commissioning of process equipment.

Winnipeg, Canada Area

- Process documentation, user requirement specifications, functional requirement specifications, block flow, process flow, piping and instrumentation drawings.- Procurement, installation and commissioning of process equipment- Process modeling and simulation (excel, schedulepro).- Generate project plans, scheduling, budgets. - Risk management (FMEA, HAZOP, PHA)- Generate new and revisions to engineering procedures - Generate new and revisions to maintenance… Show more - Process documentation, user requirement specifications, functional requirement specifications, block flow, process flow, piping and instrumentation drawings.- Procurement, installation and commissioning of process equipment- Process modeling and simulation (excel, schedulepro).- Generate project plans, scheduling, budgets. - Risk management (FMEA, HAZOP, PHA)- Generate new and revisions to engineering procedures - Generate new and revisions to maintenance procedures- Responsible for department goals and reporting, staffing, budgeting and financials. Show less

Winnipeg

- Facility and process design, construction and startup of a cGMP bacterial fermentation plant. Clean rooms, process equipment and utilities. - Generate maintenance instructions for all process equipment in above facility.- Responsible for department goals and reporting, staffing, budgeting and financial.- Support regulatory submissions and audits with FDA, Health Canada, MCA and others. - Partial list of additional process projects include : Cartoning & Shrink-wrapping… Show more - Facility and process design, construction and startup of a cGMP bacterial fermentation plant. Clean rooms, process equipment and utilities. - Generate maintenance instructions for all process equipment in above facility.- Responsible for department goals and reporting, staffing, budgeting and financial.- Support regulatory submissions and audits with FDA, Health Canada, MCA and others. - Partial list of additional process projects include : Cartoning & Shrink-wrapping Line, Capper, Syringe Filler, PW, WFI, Clean Steam Show less

Winnipeg, Canada Area

- Scale-up source plasma process 8x.-Generate baseline design criteria for other facility consultants. Engineering design for process equipment and sanitary utilities. - Site construction supervision and equipment installation. - Qualification and Validation of the new manufacturing area (clean rooms and HVAC, process equipment, CIP, PW, WFI, clean system, utilities)- Maintain all facility and process drawings- Support regulatory submissions and audits with FDA, Health… Show more - Scale-up source plasma process 8x.-Generate baseline design criteria for other facility consultants. Engineering design for process equipment and sanitary utilities. - Site construction supervision and equipment installation. - Qualification and Validation of the new manufacturing area (clean rooms and HVAC, process equipment, CIP, PW, WFI, clean system, utilities)- Maintain all facility and process drawings- Support regulatory submissions and audits with FDA, Health Canada, MCA and others. Show less

Winnipeg, Canada Area

Winnipeg

- Support repair and overhaul of gas turbine components

Winnipeg, Canada Area

- Forecasts for Hydraulic Cylinders and Contractor Equipment - Support territory managers and original equipment manufacturer accounts.

Crm, Risk Management

Activities and Societies: RRIM

B. Sc. Agricultural Engineering, Dean'S Honor List