Your NewpanyA leading and well-established manufacturing organisation within the medical device sector is seeking a Project Validation Engineer to join their Technical/Process Engineering team. This is an excellent opportunity to work in a regulated environment, contributing to high-quality, innovative products.
Your New RoleReporting to the Senior Process Engineer, you will be responsible for the management and coordination of validation activities for equipment, processes, and materials. You will collaborate with internal teams, external contractors, and suppliers to ensure all validation activities are delivered in line with regulatory andpany standards. Key responsibilities will include planning, reviewing, approving, and executing validation documentation including SOPs, protocols, deviations, and change controls. Leading validation activities across the full project lifecycle, from design throughmissioning and qualification. Ensuringpliance with EU, US, and ICH regulatory requirements and reviewing vendor validation documentation to ensure alignment withpany standards Supporting and implementing change control processes and providing validation expertise across the site.
What You'll Need to SucceedIdeally you will have:
1. A degree in Engineering, Science, or a related discipline (or equivalent experience)
2. Experience in validation within a regulated environment, ideally medical devices
3. Proven experience in validation execution and lifecycle management
4. Strong statistical analysis and process capability knowledge
5. Excellent report writing and documentation skills
6. Experience working cross-functionally within multidisciplinary teams
7. Knowledge of EU/US regulatory requirements and validation standards
8. Lean/Six Sigma training (advantageous)
What You'll Get in Return
9. Opportunity to work on high-impact, regulated projects
10. Career development within a growing and innovative organisation
11. Collaborative and supportive team environment