Sean Charley Email and Phone Number
Sean Charley work email
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Sean Charley personal email
SC Consultants Ltd (Owner)CQV & Project management consultancy, focusing on manufacturing, process, validation and infrastructure solutions within the Pharmaceutical, Bio-pharmaceutical and Medical Device sectors.Specialist solutions:Project managementEquipment specification, procurement & CQVViral Vector upstream / downstream - Bioreactors / Aseptic Fill - FinishUtilities project management installation & commissioningValidation - Equipment, Process, CSVProcess optimisation CAPA, Non conformance & Change managementRisk Management (RA, pFMEA, HAZOP, dFMEA, FMECA)IVDD - Design & Process optimisationNew Product Introduction (NPI)Design for Manufacture & Assembly (DFMA)Clean room, Clean gases commissioning & validationAseptic filling, packaging & sterilisationAsset Management (OEE, PPM, TPM, Lean)Automated assemblySAP, Maximo, Trackwise, Master Control, Proquis, JD Edwards, MAPS
Gencell Technical Services
View- Website:
- gencellprojects.com
- Employees:
- 14
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Gencell Technical ServicesLangham, Gb
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Senior Cqv Engineer At Complete Technical Solutions LtdComplete Technical Solutions (Cqv) Ltd. Aug 2023 - PresentValidation, Verification & Commissioning at University of Sheffield -
Senior Cqv EngineerGtimc - The University Of Sheffield (Gene Therapy Innovation And Manufacturing Centre) Jan 2024 - Sep 2024Commissioning, Qualification and Validation of site services, research and manufacturing equipment
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Senior Cqv EngineerTouchlight Aug 2023 - Jul 2024Hampton, London, England, GbCommissioning & Validation of Bio-Tech Laboratory / Processing Equipment -
Lead Validation EngineerOsler Diagnostics Oct 2021 - Aug 2023Oxford, GbValidation of manufacturing processes and laboratory equipment. -
Senior Cqv ConsultantFujifilm Diosynth Biotechnologies Apr 2021 - Oct 2021Billingham, GbVaccine expansion projectsBioreactor Commissioning & ValidationBuildings & Cleanroom Validation -
Senior Cqv ConsultantOxford Biomedica May 2019 - Apr 2021Oxford, Oxfordshire, GbViral Vector Fill / Finish automation & CSVCovid - 19 Vaccine manufacture scale-up -
Senior Validation ConsultantStryker Jun 2018 - May 2019Kalamazoo, Mi, UsFDA Audit remediation validation and CSV system reviews of manufacturing equipment and processes, for the production of Orthopaedic implants.Labelling system integration into Stryker Global systemFDA Audit remediation preparationProduction equipment validation -
Validation Manager ConsultantPorton Biopharma Ltd Jul 2017 - Jun 2018Salisbury, Wiltshire, GbValidation of Pharmaceutical manufacturing process equipmentTech Transfer projects & Pre Clinical Trial -
Project Manager Consultant - Infrastructure/Facilities - UtilitiesGlaxosmithkline Pharmaceuticals Mar 2016 - Jun 2017Brentford, Middlesex, GbHVAC and Clean room upgrades to tablet manufacturing and respiratory inhaler manufacturing processes -
Validation ConsultantSiemens Healthcare Diagnostics Oct 2015 - Mar 2016Forchheim, DeCSV & Process review of new data management system for diagnostics test equipment assembly line.eDHR (Electronic Device History Record)Configuration SpecificationQMPData Events MatrixData System IQProcess VP, URS, IQ, OQ -
Qe & Validation ConsultantBespak Jul 2014 - Sep 2015Holmes Chapel, England, GbValidation documentation of automated equipment assembly for Medical Device components.Quality Engineering validation documentationQE Notification managementOEM Design QualificationsRisk Analysis (dFMEA, pFMEA)SAP -
Project Engineer Consultant - NpiPhilips Design Jan 2014 - Jul 2014Amsterdam, Noord-Holland, NlProject management for new product, automated assembly line procurement, installation, validation documentation and commissioning -
Project Engineer Consultant (Mech Eng) - Site Services/Facilities/ProcessJohnson Matthey Jun 2012 - Dec 2013London, Greater London, GbLead Mechanical Project engineer at Johnson Matthey European Catalyst Technology Division.Operating within a Project Management team on a €65 Million new manufacturing facility in Eastern Europe,Project managing all site Services/Facilities specification, procurement & installation. -
Validation Engineer - Medical (R&D)Olympus Key Med Jun 2011 - May 2012Hamburg, Hamburg, DeFull retrospective Validation of Manufacturing site, including Medical Device mechanical automated equipment processes, Electronic assembly equipment automated processes, CSV (21CFR part 11) Electronic records, Medical component R&D -
Senior Process Development EngineerSphere Medical Limited Oct 2006 - Jun 2011New Product Introduction Process optimisationEquipment procurementValidation of process, equipment & cleanroomProduct design & DFMAElectronics assembly & contractor managementInjection mould designComponent assembly, packaging Contractor project management -
Manufacturing Engineer (Projects)Johnson & Johnson Feb 2004 - Oct 2006New Brunswick, Nj, UsHigh volume Diabetes strip manufactureProduction Improvement through Lean toolsTPM, VSM, Six sigmaEquipment procurement, Installation & ValidationManagement of Quality & volume driven production improvement projectsManagement of Maintenance Engineering Improvement Projects -
Operations Engineering Team LeadJohnson & Johnson Dec 2001 - Jan 2004New Brunswick, Nj, UsManagement of shift maintenance engineersProduction & Facilities maintenanceEquipment Installation & ValidationLean improvement projects
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Equipment EngineerInverness Medical Limited Feb 1998 - Nov 2001Manufacturing and Facilities Equipment procurement, installation, maintenance and development.
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Quality ManagerPilbeam Racing Designs Limited Mar 1997 - Feb 1998Fabrication compliance for race car upgrades, including Ford rally car & Peugot touring car.
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F1 Engine Development Test EngineerCosworth Feb 1995 - Mar 1997Northampton, GbTest and Development of F1 and Indy car engines.Involved with Crank, Cam, Valve and Cooling sytem development. -
Missile Systems EngineerBae Systems Feb 1990 - Feb 1995London, GbMissile procurement and testing
Sean Charley Skills
Sean Charley Education Details
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Anglia Ruskin UniversityMechanical Engineering -
The Open UniversityEng Technology/Mechanical Engineering
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The Open UniversityDesign & Innovation
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The Open UniversityProject Management Systems / Prince 2
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Raf Technical Training CollegeAeronautical And Electrical Engineering
Frequently Asked Questions about Sean Charley
What company does Sean Charley work for?
Sean Charley works for Gencell Technical Services
What is Sean Charley's role at the current company?
Sean Charley's current role is SC Consultants Limited - CQV, Process, Project Management Consultancy Services.
What is Sean Charley's email address?
Sean Charley's email address is se****@****o.co.uk
What schools did Sean Charley attend?
Sean Charley attended Anglia Ruskin University, The Open University, The Open University, The Open University, Raf Technical Training College.
What are some of Sean Charley's interests?
Sean Charley has interest in Politics, Environment, Human Rights, Animal Welfare, Arts And Culture, Health.
What skills is Sean Charley known for?
Sean Charley has skills like Validation, Manufacturing, Medical Devices, Product Development, Project Management, Iso 13485, Engineering, R&d, V&v, Gmp, Design For Manufacturing, Six Sigma.
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