Steve Coventry Email & Phone Number

Vancouver, Bc, Ca

Vancouver, Canada Area

Manage the Process Engineering group in the Process Development department

Vancouver, Bc

Burnaby, Bc

- Led a team in the successful 10X scale-up of a complex pharmaceutical manufacturing process to allow production at scales required to meet commercial supply requirements. - Designed multiple pieces of complex equipment for the manufacture of drug product per GMP. Duties included general design, development of RFP’s, selection of equipment fabricators based on technical and budgetary considerations, review and approval of technical drawings and documents, and start-up and commissioning of the equipment. - Troubleshot process operations, leading to improved and streamlined operations. - Assisted in planning and forecasting activities to accurately define the scope of work, timeline, and resource requirements for a complex, multimillion dollar government contract. - Wrote and reviewed SOPs, Specification documents, and Batch Production records to ensure technical accuracy and compliance to Good Manufacturing Processes.

San Jose, California

As part of the validation team, ensured that process equipment used in a pharmaceutical manufacturingfacility was validated to conform to regulatory requirements.Performed commissioning activities on pharmaceutical equipment to prepare equipment for validation.Planned, wrote, and executed equipment validation protocols.

Vancouver, Canada Area

As part of the engineering team, ensured the successful construction, validation, and operation of amultimillion dollar pharmaceutical fill/finish facility:-Performed the design, start-up, and commissioning of numerous pieces of skidded process equipment(Lyophilizer, WFI/Clean Steam system, RO Water System, Depyrogenation Oven)Maintained tight project timelines and budget control during the construction phase through active, ‘onthe floor’ management of, and consultation with, various project participants (owner, General and Sub-Contractors, Building Trades, outside A&E firm personnel).-Aided the successful Validation of the facility through detailed technical review and approval of validationprotocols. Served as a technical resource to more junior personnel executing the protocols.-Transferred processes from laboratory to pilot plant scale-Fostered a team environment which successfully addressed and managed competing stakeholder priorities.-Increased the reliability and efficiency of a high value manufacturing process at an off-site contractmanufacturing facility through the design and implementation of an automation and mechanical upgrade.Designed process, oversaw project management, and reviewed work performed by independent softwareprogrammers and mechanical contractors.

Greater St. Louis Area

Successfully led the validation of a PLC based Networked Control System for the Tissue Culture suite.Team was comprised of system integrators and in-house engineers working under tight project timelines.Managed design, installation, start-up, and commissioning of various pieces of pharmaceutical productionequipment (CIP Skids, Equipment Washers, Process Vessels). Supervised work performed by equipmentmanufacturers and building contractors including pre-delivery factory inspections of equipment, andextensive field testing of equipment during the start-up and commissioning phases of the project.Supported facility efficiency by designing multiple production suite automation sequences, including CIP,SIP, and Process Transfer sequences.Ensured facility regulatory requirements were met by writing Validation Protocols (DQ, IQ, OQ, PQ) andStandard Operating Procedures for control systems and process equipment.Performed scale up experiments on various fermentation and purification production techniques. Productionsteps included fermentation, centrifugation, homogenization, chromatography and tangential flow filtrationsteps.

Mississauga, On

Supported increased production efficiencies by scaling-up a recombinant protein purification process fromlaboratory to pilot scale.Ensured successful validation of a cGMP manufacturing process by designing and performing scaled downlaboratory experiments.