NPI & Validation Project Engineer

Theo James Recruitment Ltd

Stockton-on-Tees

On-site

GBP 40,000 - 46,000

Full time

2 days ago

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Benefits offered by this job

Competitive benefits package

Ongoing training and professional dev.

Supportive, engineering-led env.

NPI & validation projects opportunity

Long-term career progression

Job summary

Theo James Recruitment Ltd is assisting a medical manufacturing business in Stockton-on-Tees to appoint a Project Engineer. You will lead and deliver NPI and validation projects, focusing on process validation, PPAP documentation and ensuring processes meet customer and quality requirements.

You will support projects from feasibility through development, validation and handover into production, working with Engineering, Quality and Operations in a regulated environment to maintain traceability

Qualifications

Experience in process validation and manufacturing quality requirements.
Experience preparing or supporting PPAP submissions and FMEAs.
Background in a regulated manufacturing environment (medical devices, pharma, automotive, aerospace).

Responsibilities

Lead and support process validation activities with validation plans, protocols and reports.
Prepare, coordinate and maintain PPAP documentation and submissions.
Develop and maintain Process Flow Diagrams, FMEAs and supporting quality documentation.
Ensure projects comply with internal quality procedures, customer specs and regulatory requirements.
Support NPI projects from feasibility to validation and production handover.
Collaborate with Quality and Production to manage risks and implement corrective actions.
Maintain engineering records, BOMs, specifications and documentation.
Coordinate activities to meet quality, cost and delivery targets.