Process Engineer II

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Process Development Engineer II Key ResponsibilitiesPrevious new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage; in particular strong knowledge and application of process and equipment validation techniques, PFMEA's, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.Demonstrates strong technical expertise on process/product technologies to support selection, design, optimisation, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies.Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performanceDemonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.Liases with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment. And summarizes, analyses and draws conclusions from test results leading to effective technical resolution.Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks as required.Demonstrates a primary commitment to patient safety and product quality.Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.Understands and complies with all the regulations governing the quality systems.Travel to other sites / vendors as part of Technology development & transfer activities. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable:Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.Establishes and promotes a work environment that supports the Quality Policy and Quality System. Minimum Education and Experience Honours Degree - HETAC Level 8 in relevant Technical disciplineMinimum of 3 years post graduate experience.Strong technical experience preferably in the health care industryExcellent interpersonal and communication skills.Excellent analytical and problem-solving skills.Candidates should have a proven track record of working in a fast-paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales