The Validation & Compliance Engineer will ensure that all tooling, equipment, and production processes meet required validation, compliance, and documentation standards. This key role supports internal operational control and external customer engagement, enabling efficient progression from RFQ through to approved production.
The position requires strong technical documentation capability, cross‑functional collaboration, and a disciplined approach to validation activities across multiple customer programmes.
Key Responsibilities
- ISIR documentation including IQ, OQ and PQ reports
- Development of validation protocols and execution of validation activities
- Completion and maintenance of compliance documentation.
- Preparation of Product Part Approval Process documentation.
- Completion of FMEA documentation including PFMEA and DFMEA
- Management of change control documentation.
- Creation of standard work instructions for SCAR completion.
- Collaboration with Quality, Production and Tooling to reduce internal NCRs.
- Provision of structured documentation to support rapid customer engagement
- Completion of Mould Repair Assessment documentation
Required Skills & Competencies
- Strong technical writing and documentation capability
- Ability to interpret customer specifications and regulatory requirements
- Effective cross‑functional communication
- Structured, methodical approach to validation and compliance activity
Relevant Qualifications Required
- Minimum HNC in Engineering or Quality (or equivalent technical discipline)
- Understanding of validation methodologies including IQ/OQ/PQ
- Knowledge of quality management systems (ISO 9001 or equivalent)
- Competence in FMEA methodologies (PFMEA / DFMEA)
- Experience with change control processes within a manufacturing environment
- Proficiency in technical documentation and structured reporting
Desirable Qualifications & Experience (Not Essential)
- Six Sigma Yellow/Green Belt
- Training or certification in continuous improvement methodologies
- Experience with MRP systems
- Familiarity with Sage or equivalent ERP platforms
- Exposure to regulated manufacturing environments (medical, defence, aerospace, or similar)
Candidate Profile
The ideal candidate will be a technically capable individual with experience in validation, compliance, or quality documentation within a manufacturing or engineering environment. They will demonstrate strong organisational skills, a disciplined approach to documentation, and the ability to support both internal teams and external customer requirements.
Pay: £38,000.00-£42,000.00 per year
Work Location: In person
