Process & Validation Engineer

Description:

We are seeking a Process & Validation Engineer to work for a medical device manufacturer in West Sussex.

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.

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 the validation systems and ensuring that projects are properly documented and handed over into production.

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.

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

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.

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.

Key words: validation engineer validation specialist validation consultant validation manager validation coordinator medical device engineer medical device engineering blow mould engineer injection mould engineer mechanical engineer process engineer process improvement engineer manufacturing engineer production engineer medical device specialist