Senior Validation Engineer
GSK (GlaxoSmithKline) plc.
Total years of experience :15 years, 0 Months
▪Applied V-Model concept for legacy and newly introduced computer and analytical systems.
▪Developed validation plan for systems being qualified.
▪Performed all sorts of machine testing (design qualification, compliance determination, installation qualification, operation qualification and performance qualification) to ensure that Analytical and control systems are fit for the intended use.
▪Perform process risk assessment and contributed in FMEAs.
▪Perform qualification and calibration activities:
▪Analytical equipments qualification.
▪Sterilizing autoclaves qualification.
▪Depyrogenation tunnel and oven qualification.
▪LAFs and air systems qualification.
▪Warehouse and incubators thermal mapping.
▪Calibration of balances, checkweighers and manufacturing machines.
▪Ensure that all used GMS systems (computerized/non-computerized) and site facilities follow the GSK standards and guidelines.
▪Apply lean manufacturing through GPS (GSK Production System) through 5s, GEMBAs, problem solving and operator standard work.
▪Create and develop calibration and validation SOPs (Standard Operating Procedures).
▪Contribute in deviation handling and problem solving.
▪Performed L1 audits and developed CAPAs (corrective and preventive action)
▪Validation of Excel spreadsheets.
▪Installation and maintenance of machines in major pharmaceutical Companies like Sanofi-Aventis, Global Napi, Amoun, SEDICO, EIPICO, and El-Gomhouria.
▪Accountable for sales and after sales of Helvoet Pharma (Datwyler Group) and EPMO (Elizabeth Group).
▪Machine selection according to customer needs.
▪Installation and maintenance of Korean pharmaceutical machines:
Sejong: Rotary Table Press, Automatic Capsule Filling Machine.
Hoong-A: Automatic Blister Packaging Machine, Continuous Motion Horizontal Cartoning Machine.
Countec: Electronic Multi-channel Counter, Sachet Silica Gel Inserter, Cotton Wool Inserter, In-Line Screw Capper.
Yoosung: Vial Washing and Sterilization Machine.
▪Performing IQ/OQ Protocols.
▪Preparation of all arrangements and procedures including offers and Bid Bonds to Join Governmental Tenders.
▪Contributed in design and execution of air conditioning and ventilation systems.
▪Involved in Maintenance of diesel engines and chillers.
▪Contributed in design of water pipe lines.
B.Sc. of Mechanical Power Engineering from Ain Shams University 5 Years Study GPA: Good Graduation Project Grade: Distinctive Awards: ▪Qualified to the finals in MIE (Made in Egypt) competition for graduation projects. ▪Qualified to the finals in EED (Egyptian Engineering Day). ▪Awarded financial and technical sponsoring from Nahdet El Mahrousa NGO. ▪Certificate of excellence in high school.