Salary: £40,000 – £46,000
Location: Stockton-on-Tees
Benefits:
* Competitive benefits package
* Ongoing training and professional development
* Supportive engineering-led working environment
* Involvement in technically challenging validation and NPI projects
* Long-term career progression
The Company:
Theo James Recruitment is proud to be supporting an established medical manufacturing business in Stockton. Operating in a quality-focused, regulated environment, the business is committed to robust manufacturing processes, technical excellence and continuous improvement.
This opportunity will suit an engineer who enjoys the detail behind process validation, technical documentation and ensuring manufacturing processes are capable, controlled and ready for production.
Job Description:
As a Validation Engineer, you will play a key role in planning, coordinating and documenting validation activities across New Product Introduction (NPI) and manufacturing projects. Working alongside Engineering, Quality, Operations and customers, you will help ensure processes meet defined specifications, customer requirements and applicable quality procedures before production approval.
Key responsibilities include:
* Prepare and maintain process validation plans, protocols, reports and supporting technical evidence.
* Coordinate validation activities, review results and document any issues, deviations and corrective actions.
* Support preparation of customer-specific PPAP submissions and associated approval documentation.
* Develop and maintain Process Flow Diagrams, FMEAs and controlled engineering records.
* Work with Engineering and Quality to identify process risks and demonstrate manufacturing readiness.
* Support NPI projects through feasibility, process development, validation, customer approval and production handover.
* Maintain accurate records and traceability in line with internal procedures, customer specifications and relevant regulatory requirements.
* Collaborate with cross-functional teams to resolve technical issues and improve process consistency and documentation.
Skills & Experience:
* Experience in a Validation Engineer, Process Engineer, Manufacturing Engineer, Quality Engineer or related technical role.
* Practical knowledge of process validation, validation documentation and manufacturing quality controls.
* Experience with PPAP, FMEA, Process Flow Diagrams or similar structured approval documentation.
* Background in a regulated or tightly controlled manufacturing environment, such as medical devices, automotive, aerospace or pharmaceuticals.
* Experience supporting NPI, process introduction, qualification or transfer into production.
* Ability to interpret engineering drawings, specifications and technical manufacturing data.
* Strong attention to detail, document control and cross-functional communication skills.
* Engineering degree or relevant technical qualification preferred.
If you have a strong background in validation and enjoy ensuring manufacturing processes are robust, documented and compliant, we would be keen to hear from you
Salary description
£40000.00 - £46000.00 per year