NPI & Process Validation Engineer

Theo James Recruitment Ltd; Tees Valley; Presencial; GBP 40.000 - 46.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits package

Ongoing training and professional dev.

Supportive engineering-led working env

Involvement in technically challenging

Long-term career progression

Descripción de la vacante

Theo James Recruitment Ltd is supporting an established medical manufacturing business in Stockton for a Validation Engineer. You will plan, coordinate and document validation activities across NPI and manufacturing projects, ensuring processes meet specifications and customer requirements before production approval.

Key responsibilities include preparing validation plans and reports, coordinating activities, assisting PPAP submissions and maintaining engineering records with attention to detail

Formación

• Experience in a Validation Engineer or related technical role.
• Practical knowledge of process validation, validation documentation and manufacturing quality controls.
• Experience with PPAP, FMEA, and process documentation.
• Background in a regulated or tightly controlled manufacturing environment (medical devices, pharma, automotive, etc.).
• Experience supporting NPI, process introduction or transfer to production.
• Ability to interpret engineering drawings, specifications and manufacturing data.

Responsabilidades

• Prepare and maintain process validation plans, protocols, reports and supporting technical evidence.
• Coordinate validation activities, review results and document issues, deviations and corrective actions.
• Support preparation of 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 and regulatory requirements.
• Collaborate with cross-functional teams to resolve technical issues and improve process documentation.

Conocimientos

Process validation

PPAP

FMEA

Document control

Cross-functional communication

Engineering drawings interpretation

Educación

Engineering degree

Descripción del empleo

Theo James Recruitment Ltd is supporting an established medical manufacturing business in Stockton for a Validation Engineer. You will plan, coordinate and document validation activities across NPI and manufacturing projects, ensuring processes meet specifications and customer requirements before production approval.

Key responsibilities include preparing validation plans and reports, coordinating activities, assisting PPAP submissions and maintaining engineering records with attention to detail