Process Validation Engineer

Cyden Ltd; Swansea; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading engineering company in Wales is seeking a Process Engineer to join their team. The role involves supporting New Product Introductions through documentation and process validation while optimizing manufacturing processes. Successful candidates will have a technical background and a strong understanding of process improvement methodologies. The position offers competitive pay and various employee benefits including a pension scheme and career development opportunities.

Benefits

25 days holiday plus bank holidays

5% company pension contributions

Employee Assistance Programme

Cycle to Work Scheme

Qualifications

• Understanding of Industrialisation processes.
• Experience managing validation projects and compliance.
• Ability to handle continuous improvement activities.

Responsibilities

• Develop technical understanding and manage Industrialisation processes.
• Create process documentation and support manufacturing tasks.
• Identify and implement continuous improvement opportunities.

Skills

Technical understanding of products

Process documentation creation

Collaboration with design teams

Continuous improvement

Data analysis techniques

Tools

Power BI

Job description

Social network you want to login/join with:

Working in the Engineering team alongside both Development and Operations departments. The jobholder will be part of a team of Process Engineers ensuring smooth New Product Introduction (NPI) into production, focusing on process development and improvement of all production line equipment and documentation to ensure maximum productivity, quality, and safety.

RESPONSIBILITIES:

The role involves developing a thorough technical understanding of our products and managing all aspects of the Industrialisation process, including:

• Producing Industrialisation Documentation: Standards, Intent, Requirements, Database, Validation
• Creating Process Documentation such as DFM, PFMEA, Process Flow Charts, Capacity Plans, Control Plans, Layouts, Work Instructions, etc.
• Participating in hands-on build and review during NPI Builds.
• Offering improvement ideas to optimize manufacturing processes in collaboration with the Design team.
• Continuously improving production processes to adapt to changing product development needs.

Support Process Validation Activities:

• Identifying validation requirements, including specifications and sign-off criteria.
• Managing validation projects to meet deadlines.
• Performing IQ, OQ, PQ validation processes and ensuring documentation compliance with regulatory standards.
• Participating in audits as required.

Support Manufacturing Tasks:

• Assessing new processes for equipment needs, control points, etc.
• Conducting Gauge R&R and equipment capability studies.
• Producing or reviewing PCNs, ECNs, concessions, and registers.

Investigate and Implement Continuous Improvement Activities:

• Managing continuous improvement projects and implementing changes.
• Researching and developing data analysis techniques and innovations such as Power BI and KPI dashboards.
• Identifying opportunities for process improvements in new and existing processes.

These responsibilities are not exhaustive; the post holder is expected to perform any reasonable tasks assigned by their Line Manager to support business needs. Specific responsibilities and authorities are outlined in relevant procedures.

In return, we offer competitive pay, 25 days holiday plus bank holidays (rising to 30 with service), 5% company pension contributions, sick pay, career development opportunities, Employee Assistance Programme, and Cycle to Work Scheme.

CyDen is committed to being an equal opportunities employer and values diversity.