Process & Validation Engineer

Process & Validation Engineer – Injection Moulding

Join a growing UK medical device manufacturer

Our client is a privately owned, family-run medical device contract manufacturer based in Littlehampton, West Sussex.

They are continuing to grow and are looking for an experienced Process & Validation Engineer to join their team and help them 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.

The role

As Process & Validation Engineer, you will play a key role in developing and implementing best-practice process, validation and statistical methodologies across their MouldShop and Cleanroom Production areas.

You will be responsible for organising and executing moulding validations, supporting new product and process introductions, improving their 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

* Organise and execute injection moulding validation protocols, including risk management and validation activities.

* Develop and maintain robust validation documentation and ensure validation requirements are fully met.

* Ensure complete and accurate handover packages are produced following validation.

* Oversee metrology and validation activities for new and existing projects.

* Contribute to the preparation, review and continual improvement of the Validation Master Plan.

* Support the development and upgrading of validation procedures and systems.

* Monitor and report monthly production scrap and identify opportunities for improvement.

* Apply statistical and validation methodologies to manufacturing and quality activities.

* Provide technical and validation support to the Quality team.

* Provide backup support for final product release when required.

* Work with customers and suppliers where necessary, including occasional visits to customer sites.

About you

They are looking for someone who is technically capable, organised and enjoys solving problems.

You will ideally have experience working in validation, quality control, metrology, process engineering or a similar role within a regulated manufacturing environment.

You should have:

* 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.

* A good understanding of statistical and validation methodology.

* 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.

Additional benefits:

Employee health cash plan

Company pension

Onsite parking

Free tea and coffee provided

2 annual parties

Working Hours

Monday to Thursday, 8am to 5pm (or 7am to 4pm)

Friday, 8am to 1.30pm (or 7am to 12.30pm).

39.5 hours per week