We are looking for an individual to be part of the technical team that provides engineering solutions for Product life cycle from New Product Introduction, Equipment and Process installation and validation through to Process Improvement, capacity expansion and cost saving projects.
You will use process technical knowledge to evaluate new and existing processes and configure manufacturing systems to reduce cost and waste, improve efficiency and develop best practices to drive optimisation of the existing manufacturing environment.You will also work across departments (including Operations, QA/Validation and R&D) to support delivery of the next generation of innovative and creative manufacturing solutions, new product implementation/launch and business growth.
What You'll Be Doing
* Always ensure maintenance of regulatory compliance.
* Work with the Process Engineering and Production teams to support delivery of Capital and Process Improvement projects and support the technical team to maintain reliable and safe manufacturing systems.
* Evaluate existing manufacturing processes by gathering observations from operators, process SMEs and equipment manufacturers. Use this evaluation to implement small projects designed to improve production rates and capacities, efficiencies, yields, costs and product quality.
* Utilise Root Cause Analysis methods to problem solve process issues and increase equipment reliability, process capability and product quality.
* Where necessary, organise and perform process and equipment validation to appropriate regulatory standards for the Medical Device Industry.
* Work closely with R&D and QA/Validation departments to support the development, validation and transfer of new products into manufacturing, as well as supporting the implementation of the next generation of processing equipment using innovative technologies.
* Help to identify, draft and implement Standard Operating Procedures for new processes and equipment.
* Develop strong working relationships with other departments, external partners, suppliers and consultants to support delivery of successful projects that will impact company performance.
* Maintain a high standard of professional and technical knowledge by attending educational training/workshops; reviewing professional publications; establishing networks; participating in professional societies.
* Carry out all duties in accordance with the Health and Safety Policy and procedures.
* Undertake other duties appropriate to the level and character of the work as may reasonably be required by the Company.
What Experience Do You Need
* Minimum 3 years’ experience working with manufacturing equipment in a GMP environment.
* Practical working knowledge of manufacturing processes and/or process improvement and/or validation of equipment and processes.
* Experience with Change Management and working in a highly regulated environment.
* Solid knowledge of Health and Safety best practices and working in a live manufacture environment.
* Basic Statistical Analysis knowledge.
* Desirable: BTEC/HNC/HND/BEng/Meng Engineering degree or equivalent appropriate qualification/experience.
* Working in healthcare/pharma/medical devices industry.
* A working awareness of medical device regulations and the medical device directive (ISO13485, FDA QSR 21, CFR 820 etc).
* Experience with data Analysis and statistics software.
* Project Management experience.
What We Can Offer You
* Private healthcare
* Wellbeing allowance up to £300.00 a year
* Monthly yoga sessions and quarterly massages
* Annual programme of fun events
* On site restaurant
* Enhanced maternity & paternity leave
* On site parking
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