- 01295 266288
Contact Mayday about this job today!
Our prestigious partner is an industry-leading global player, developing and manufacturing pioneering medical products under their own brand as well as providing custom device solutions for the world’s leading pharmaceutical and diagnostic companies.
The Process Improvement Engineer will, as part of a local engineering team, provide direct engineering support to production in order to improve and sustain products / processes at maximum possible efficiencies and quality levels. Continuously monitoring and improving performance against targeted KPIs & metrics, the Process Improvement Engineer shall investigate and resolve any non-conformance of efficiency issues that may occur, driving any engineering changes required.
Duties include (but not limited to)
- To proactively monitor equipment and process performance to control and react to adverse trends and deliver improved performance
- Investigate any machinery/process or product performance and quality problems. Carrying out root-cause analysis, identifying and implementing permanent solutions
- To develop approved validation rationales as required within the validation guidelines
- To be responsible for the generation and approval of robust documentation and specifications associated with validations (change control, validation plans, protocols, FMEA’s, reports, gauge R&R studies etc)
- Ensure that Change Control and Validation is completed in line with agreed project plans and documented to the required standard, conforming to Owen Mumford SOP’s and GMP
- To execute and document validations, process optimisations and misc. trials as required
- To ensure complete handover packages are compiled and available within manufacturing to ensure smooth introductions to production
- To provide input into management monthly report on metrics, monitoring and trending to identify and justify improvement areas
- To work cross-functionally in formal and informal project teams in order to complete assigned tasks
- To support Industrialisation and product introduction activities as required
- Support the production managers re: audits (internal and external), Change Contol, CAPA’s, EWR’s, NCR’s, Work Instructions and work flow studies
- Working with assigned maintenance engineers to create PPM schedules and assist with maintenance duties and delivery of improvements
- Participate if required to in engineering activities scheduled during plant shutdowns e.g. Christmas/public holidays
- The achievement of all agreed personal objectives.
- The rigorous application of all company GMP principles and practices
- To liaise with the customer on performance, projects and Technical activities associated with Assembly & printing processes.
- Ensuring Health and Safety disciplines defined in the company Health and Safety policy document with reference to Health and Safety at work act 1974 are followed and enforced
- Any other duties as required by the Cotswold Production Management, or other employee as designated by the General Manager
You will be/have
- NVQ level 3 in associated topic
- HNC in a related engineering subject
- Understanding of lean and Six Sigma principles
- Knowledge of Plastic injection moulding, automatic and manual assembly, Pad printing
- Medical device manufacturing experience
- Generation of technical reports
- Process improvement, problem solving and validation experience
- Fully computer literate with MS Office and Minitab
- Working knowledge of current safety regulations and legislation
- Relevant working knowledge in a regulated industry and GMP
- Ability to demonstrate theoretical knowledge with practical application
- Practical problem solving, and communication skills are essential
What’s on offer?
- A competitive salary – call me for details.
- Full access to the company’s wonderful benefits scheme.
- The opportunity to work within the company’s flexible working scheme.
If you have read this job description and would like to apply, please send an up to date CV to email@example.com. For more information, please call 01295 266288 and speak to Matt. I look forward to hearing from you!