Senior Materials Engineer - Blackpool
CK Group is recruiting for a Senior Materials Engineer to join a company in the Medical Devices industry at their site based in Blackpool on initially a 6 month contract basis. Our Client: Our client is part of a family of companies owned by one of the worlds largest pharmaceutical companies. Specialising in Medical Devices, they offer the world's most comprehensive portfolio of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials. The Location: The role is based at our client's site in Blackpool which is easily accessible by car via Junction 32 of the M6 or the M55 which will lead you almost to the beach. Blackpool train links include direct routes to Preston, East Lancashire, London, Manchester, Liverpool, York, Birmingham, Glasgow and Edinburgh. Reporting to the Materials Engineering Manager the Senior Materials Engineer will provide a lead role in the project & validation engineering of Materials Development projects. The job holder will lead the technological improvements and product transfers in conjunction with local Quality, Engineering, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion. They will also be able to successfully move between validation, project and process functions effectively. This role involves providing technical leadership working with a cross functional team to develop and validate advanced manufacturing automated systems for the implementation of leading edge technologies and innovative processes to build excellence in equipment and computer system and process validation. Duties will include: • Consolidation and validation of Project Plans and deliverables • Manage communication and work commitments with teams' external to the core team • Facilitate technical problem resolution through the application of best practice tools such as 8-D, DMAIC, etc • Define process outputs, transfer functions, process inputs. Understand sources of variation and inference spaces. Implement process characterisation and input control to attain true process validation • Understand Validation, Process and Project engineering related to job function/projects and lead the Engineering Team • Characterise product and process, including identification of CQA's and CPP's, performing DOE's to define relationship models, documenting design space, creation of control plan • Define Material Characterisation using advanced analytical techniques. Partner with key functions to understand test analysis and next specs • Facilitate process FMEA and ensure action follow-up and revisions as required. Utilize other QA risk analysis techniques as required to minimize potential risk. • Ensure that all changes and activities conform to local and corporate, statutory, legislative and regulatory requirements for GMP, HSE and Quality • Ensure project changes are tracked and actioned appropriately. Implement Engineering Change Control throughout Design/Commissioning and Site Change Control during validation/production. • Drive Validation/Verification strategies, authoring Master Validation Plans • Ensure correct use of statistical QA methods for project • Create and maintain an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and supply • Co-ordination of effective resourcing of projects and the management of individual performances to defined objectives • Support testing & sampling when necessary Background: • Bachelor Degree level qualification in Science/Engineering or Equivalent • Masters in Engineering and/or Business Administration • Minimum 5 years' experience in a Technical role • Proven Project Management experience (min 2 years' experience) • Materials characterization experience - microscopy, chemical-physical analysis, advanced analytical techniques • Proven knowledge and understanding of medical device / pharmaceutical regulated industry including FDA and GMP requirements • Working knowledge of QMS • Six-Sigma Green Belt certified Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43634 in all correspondence.