Gosport, England, United Kingdom
Profile: Electrical Engineer with 40 years’ experience of installation, commissioning, servicing and validation of Pharmaceutical, Cosmetic, Bio-Pharm and Medical Devices equipment including high speed blister packaging lines, High speed bottle tablet lines, OSD pharmaceutical manufacturing facilities, utilities and equipment on a global scale, Supported by 10 years’ experience in management of capital investment projects. Key Skills and Aptitude: GMP Engineering background. Excellent Communication and Interpersonal Skills. Has a passion for Engineering Excellence. Able to negotiate and present own ideas to a wide audience. Adaptable and Flexible to cope with the changing needs of the production environment. Ability to identify opportunities for process and operational improvements and implement appropriate changes to deliver these benefits. Passion for “right-first-time” processes and a determination to understand breakdown or failure to root cause and prevent re occurrence. Ability to prioritise and plan own work. Highly competent in all aspects of Engineering including Electrical, Electronic, Pneumatic, Hydraulic, Mechanical and Instrumentation. Key Achievements: Writing and Execution of validation protocols for New Oral Solid Dose Pharmaceutical Manufacturing Facility including Building Fabric, Clean Rooms, Classified Areas, Non-Classified Areas and Warehouse. HVAC Systems - Air Flows, Air Changes, Pressure Cascades, Temperature Control, Humidity Control and Temperature Mapping, EMS System - Digital Recorders, BMS System, Utilities – Purified Water, Softened Water, Compressed Air, Blender – Muller, Quadro Comil, Tablet Coater – Manesty, Compression Machines – Fette, hoists, IBC’s, IBC Washer, Granulator – Glatt, High Shear Mixer – GEA, Fluid Bed Dryer – GEA, Sieve and Dispensary – Russell Finex, Clean in Place Systems. Planning and execution of Engineering Projects, Preparation and Execution of life cycle validation documents including VMP, PVP, VP, URS, FDS, SDS, HDS, DQ, EQ, IQ, OQ, SOQ, PQ, PV, ERES, GAMP, CSV, Cleaning Validation, SIP, CIP Systems. Installation, Commissioning & Validation of high speed Blister packaging lines, High Speed Tablet Bottle lines, Bio-Pharm and Medical Devices equipment. Management of Engineering Teams and budgets. Change Control, Deviation Management, CAPA, Root Cause Analysis, SPC & Continuous Improvement Projects. Preparation of facility, equipment and documentation for FDA and MHRA audits. Highly conversant with the FDA, MHRA, ISPE, CGMP, 21 CFR Part 820, 21 CFR Part 11, ISO 13845 regulations and guidelines.
Writing and Execution of Validation protocols using Kneat for New Biopharma Manufacturing Facility including Clean Rooms, Clean Utilities, Black Utilities, Compressed Gasses and HVAC. WFI Generation – 2 x Ultrastil Ultra Filtration Skids, 2 x Pre-Treatment Skids, 2 x Osmotron WFI Generation Skids using Double Pass Reverse Osmosis and Electronic De-Ionisation. WFI Distribution – 3 x 10,000L WFI Storage tanks, 5 x LOOPO Ozonated WFI Distribution Skids, 5 x WFI Distribution Loops averaging 40 Point of Use valves. HVAC Systems – 28 x AHU’s, 5 x VHP AHU’s, Air Flows, Air Changes, Pressure Cascades, Temperature Control, Humidity Control and Temperature Mapping. Black Utilities - Chilled Water, Potable Water, Foul Drains, Storm Water, Domestic Hot Water, Domestic Cold Water, Process Waste, Solid Waste, Bio Waste. Compressed Gasses – Compressed Air, Nitrogen, Carbon Dioxide, Oxygen. Clean Rooms - 25 x Grade C (Iso 7) Clean Rooms / MAL / PAL / Changing Rooms
Writing and Execution of validation protocols for New Oral Solid Dose Pharmaceutical Manufacturing Facility including Building Fabric, Clean Rooms and Equipment. HVAC Systems, EMS System, Purified Water, Softened Water, Blender, Tablet Coater, Compression Machines, IBC’s, Hoists, IBC Washer, Granulator, High Shear Mixer, Fluid Bed Dryer, Sieve and Dispensary, Clean in Place Systems. Installation, Commissioning and validation of High Speed Bottle Filling Line and Bottle Packing Line. Management of CAPA, Deviations, Change Control, Issues and Incidents using Kneat and Veeva.
Writing and Execution of Cleaning Validation Protocols for Orals Manufacturing Facility. Writing of URS for bespoke Clean in Place System. Writing of URS for Getinge Parts Washer. Development of cleaning strategy and methods for New Product Introduction. Development of cleaning processes using Ultra-Sonication. Site Cleaning Validation SME
Writing and Execution of validation protocols for Orals Manufacturing Facility including Atex Mills, Blenders, Spray Driers, Powder Loading Rooms, Compression, Film Coaters, Chart Recorders and EMS Systems. Writing and Execution of validation protocols for High Speed Tablet Packaging Lines including Carton Coding / Verification, Serialisation and Aggregation. Writing and execution of validation protocols for a new build QA Micro Sterility testing Laboratory including Grade C Clean room, isolators, incubators, Utilities, EMS system, HVAC and grade D areas. Writing and Execution of validation protocols for Aseptic Coupling / Transfer System. Aseptic Fill Finish, Vial Washer, Dry Heat DePyrogenation Tunnel, Aseptic Filling, Bung Insertion, Capper, Inspection Systems, Coding System, Autoclave, VHP, EMS, BMS Writing and execution of Cleaning Validation protocols. Writing of Validation Documentation VP, URS, FDS, SDS, DQ, RTM, IQ, OQ, PQ, PV and VSR Deviation Resolution, CAPA’s and Change Control using SAP and MERP. Component Criticality Assessments, System Impact Assessments, and Risk Assessments. FMEA and GMP Reviews.