Process Project Engineer

• Feb 2023 - Present

Manufacturing/CQV Engineer

• Nov 2020 - Oct 2022

• • Build design/commissioning/qualification project plans for GMP equipment, Manufacturing and Storage Facilities • Develop Design Review and Design Qualification Process (DR/DQ) for GMP Equipment and Facilities supported by SOP and fillable forms • Create and review of VMPs, risk assessments, criticality assessments, quality plans, commissioning plans, URSs, IQ/OQ/PQ/ Protocols for GMP Equipment and Facilities • Lead equipment qualification projects conducted by multidisciplinary project team, which included Engineering, Maintenance, QA and QC Departments team members • Support troubleshooting for complex technical issues throughout the qualification project lifecycle • Establish calibration program for sensors controlling/monitoring critical process parameters (CPP's) • Created revalidation program for GMP Production and Storage Facilities, production, packaging and labeling equipment. • Manage investigations related to the deviations in performance of equipment and developed CAPA plans. • Conducted temperature mapping and particle counting studies as per Eudralex Volume 4, Annex 1 and WHO guidelines • Conducted Compressed Air System Qualification which included the air cleanliness study as per ISO 8573-1 Show less

Engineer, GMP Manufacturing

• Apr 2019 - Oct 2020

• Identify the department's requirements for new equipment and retrofitting of the existing equipment to increase manufacturing capacity • Develop CapEx projects scope of work and schedules • Coordinate between multifaceted teams of contractors to ensure that all the projects delivered on time, on quality, and on budget • Liaise with internal Departments (R&D, Process Development, Supply Chain, Quality Assurance and Quality Control) to streamline GMP Manufacturing processes • Serve as a key representative on multidisciplinary project teams to help define processes, equipment requirements, and quality attributes. • Participate and leads production equipment set-up for manufacturing • Provide technical expertise on mechanical aspects to the manufacture of products according to appropriate regulations and requirements (cGMP, Health Canada, etc.); • Manage calibrations, validations, corrective and preventive maintenance of manufacturing equipment, instruments and utilities • Perform routine equipment inspection and checks to assure proper performance. Ensure that all equipment, instruments and systems are properly designed, installed, tested and maintained • Support equipment troubleshooting and technical associated problems • Assist with the maintenance and operation of the manufacturing facility and critical systems • Participate in the development and implementation of procedural or automation improvement changes Show less

Equipment /Maintenance Engineer

• Aug 2017 - Mar 2019

• Raised and promoted equipment modification initiatives, enhancing productivity and safety; • Worked closely with QA, production and design teams to ensure the implementation of good manufacturing practices related to manufacturing equipment; • Performed Performance Qualifications (PQs) while introducing new technology into a production line; • Developed, planned and performed Installation and Operational Qualifications (IQ/OQs) for new and revised equipment; • Managed production equipment database, ensuring the traceability of each piece of equipment; • Submitted RFIs and RFQs; negotiated with suppliers, contractors, services providers in order to optimize the OpEx of the production and R&D equipment; • Created new, and upgraded existing preventive maintenance plans based on equipment performance data log files, using statistical analysis techniques Show less

Project Engineer/Design Site Coordinator

• Dec 2015 - May 2017

• Scheduled and conducted design review meetings between the client and multidisciplinary contractors in order to verify the feasibility of design information in the facility’s construction;• Synchronized engineering deliverables documentation flow between the engineering office and contractors on site, guaranteeing that all essential information delivered timely, ensuring the progress both design and construction projects; • Provided engineering support to contractors on site in all stages of construction, detailly explaining design packages, which contained architectural, mechanical, electrical, structural drawings, P&ID’s and layouts;• Assisted designers to create IFR and IFC packages by providing comprehensive information from the construction site, delivering all client requirements;• Coordinated between local engineering team and contractors, clarifying the scope of each project members Show less

Engineering Consultant

• Jun 2015 - Dec 2015

• Consulted on prepare and optimize the Turn Arounds’ processes by using proper piping and fittings prefabrication procedures;• Developed and monitored Turn Arounds’ KPI’s;• Assisted in evaluation of volume of works and resources, required to perform Turn Around;• Supported at risks assessment;• Consulted on strategies of contractors’ motivation; • Monitored contractors’ performance on site; • Recommended how to improve the contractors’ performance by modification of work procedures and proper space management implementation, logistics in all stages of Turn Around. Show less

Process Engineer

• Jun 2010 - Jun 2015

• Inspected construction of Oil Sands solvent extraction plant, including install, commissioning and qualifying of new equipment and utilities; • Assisted in continuous improvement of heavy mechanical and process equipment such as conveyors, mixers, settlers, heat exchangers, liquid/liquid separators, dryers, distillation columns, cooling towers, chilling units, compressors, range of pumps and blowers, wide range of utilities such as saturated steam system, vacuum, cooling and chilling water systems, firefighting system, compressed air system and air circulation system; • Revised and corrected engineering documentation such as isometries, PFD's, P&ID, BFDs, equipment lists, lay outs, mass and heat balances; • Designed, constructed and modified liquid/solid and liquid/liquid separation systems such as hydroseparators and thickeners; • Sized pumps, utilities and piping; • Identified required instrumentation for process control; • Designed and managed the construction of solids’ discharge/feeding unit; • Trained junior operators and analytical lab staff; • Provided support to the maintenance team during "on-line" works insuring safety; • Generated preventative and corrective maintenance procedures; • Built and calculated OPEX, timetables and plans; • Developed proposals and business cases in support of applications for funding for new and innovative programs or improvement opportunities; • Participated in new environmental technology research. Show less

QA Inspector

• Aug 2007 - Aug 2010

• Revised and approved API batch lists, cleaning procedures, Lab assays; • Coordinated between operating, technological, QC teams to ensure compliance GMP requirements at all stages of API manufacturing process; • Assisted at FDA and EU health departments inspections. • Revised and approved API batch lists, cleaning procedures, Lab assays; • Coordinated between operating, technological, QC teams to ensure compliance GMP requirements at all stages of API manufacturing process; • Assisted at FDA and EU health departments inspections.