Job overview
Our client, a growing medical device manufacturer in Littlehampton, is seeking a Process & Validation Engineer to develop and implement best-practice process, validation and statistical methodologies across their MouldShop and Cleanroom Production areas.
About the role
Our client is a privately owned, family-run medical device contract manufacturer based in Littlehampton, West Sussex, specialising in the manufacture of single-use medical devices and components for customers around the world. They are continuing to grow and are looking for an experienced Process & Validation Engineer to join their team and help develop and improve their manufacturing and validation capabilities. This is an exciting opportunity for someone with a background in validation, process engineering, quality, metrology or injection moulding who enjoys working in a hands-on manufacturing environment and wants to make a real difference. Their MouldShop operates within an ISO Class 8 cleanroom, with injection moulding machines ranging from 22 to 220 tonnes, alongside ISO Class 7 cleanroom assembly operations. Salary: up to £35,000 per year, dependent on experience. Hours: full-time, permanent. The role As Process & Validation Engineer, you will play a key role in developing and implementing best-practice process, validation and statistical methodologies across the MouldShop and Cleanroom Production areas. You will be responsible for organising and executing moulding validations, supporting new product and process introductions, improving validation systems and ensuring that projects are properly documented and handed over into production. You will report to the Product Quality Manager and work closely with the Mould Tooling and Technical Managers, as well as colleagues across Quality, Production and Engineering. Key responsibilities include: - Organising and executing injection moulding validation protocols, including risk management and validation activities. - Developing and maintaining robust validation documentation and ensuring validation requirements are fully met. - Ensuring complete and accurate handover packages are produced following validation. - Overseeing metrology and validation activities for new and existing projects. - Contributing to the preparation, review and continual improvement of the Validation Master Plan. - Supporting the development and upgrading of validation procedures and systems. - Monitoring and reporting monthly production scrap and identifying opportunities for improvement. - Applying statistical and validation methodologies to manufacturing and quality activities. - Providing technical and validation support to the Quality team. - Providing backup support for final product release when required. - Working with customers and suppliers where necessary, including occasional visits to customer sites. About you You will ideally have experience working in validation, quality control, metrology, process engineering or a similar role within a regulated manufacturing environment. - A solid background in validation and/or product quality control. - A good understanding of validation principles, methodologies and documentation. - Strong computer skills, including Microsoft Office and spreadsheets. - Experience working with statistical analysis; Minitab experience would be advantageous. - The ability to read and understand CAD data. - Ideally, experience or knowledge of injection moulding and polymer processing. - Good communication and customer relationship skills. - A professional and confident telephone manner. - A full UK driving licence and the ability to travel to customer sites when required. Qualifications & experience You will ideally have either previous experience in a QC, validation, metrology, process engineering or similar technical role within a comparable industry, or formal validation training and/or demonstrable validation experience from a current or previous position. Our client is more interested in your practical experience, technical ability and attitude than simply a list of qualifications — if you have the right background and are keen to develop your career within medical device manufacturing, they would be interested in hearing from you. What is on offer: employee health cash plan, company pension, onsite parking, free tea and coffee, 2 annual parties, and all bank holidays paid and offsite.
What we’re looking for
- Solid background in validation and/or product quality control.
- Good understanding of validation principles, methodologies and documentation.
- Strong computer skills, including Microsoft Office and spreadsheets.
- Experience with statistical analysis; Minitab advantageous.
- Ability to read and understand CAD data.
- Ideally, experience or knowledge of injection moulding and polymer processing.
- Good communication and customer relationship skills.
- Full UK driving licence.