Process Validation Engineer

Job description

Overall job purpose:

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, the process, development and improvement of all production line equipment and documentation that ensures maximum productivity and quality/yield, in a safe working environment.

RESPONSIBILITIES:

Developing a thorough technical understanding of our products, the jobholder’s responsibilities will include all aspects of the Industrialisation process:

Key Member Engineering Projects**:

• Part of a Team Producing Industrialisation Documentation: Standards, Intent, Requirements, Database, Validation
• Part of a Team Producing Process Documentation such as: DFM, PFMEA, Process Flow Charts, Capacity Plans, Control Plan, Layout, Work Instructions etc.
• Hands on Build and Review to Development during NPI Builds.
• Offer Improvement Ideas to Optimise Manufacturing of Product to Design team.
• Continuously Improve Production Processes to Meet Changing Product Development.

Support Process Validation Activities:

• Identify Validation Requirements (Including Specification and Sign Off Criteria).
• Project Manage Validation Activity to Ensure Overall Project Deadlines are Met.
• Perform the Validation Process IQ, OQ, PQ and Ensure Documentation is Compliant to Regulatory Requirements.
• Take Part in Audits where Required.

Support Manufacturing Tasks:

• Assess Areas of New Process that Require Equipment Studies, Control Points etc.
• Carry out Gauge R&R and Equipment Capability Studies.
• Produce and / or Review PCN’s, ECN’s, Concessions and Registers

Investigate and Implement Continuous Improvement Activities:

• Developing Initial Takt Times, OEE, Manning, Feasibilities etc.
• Managing Continuous Improvement Project Teams and Implementing Change.
• Assisting With Research and Development of Data analysis techniques and innovation e.g. Power BI, KPI dashboards etc.
• Identify any Opportunities for Improving New and Existing Processes

These tasks are not intended as an exhaustive list of the post holder’s duties. The post holder is expected to carry out any reasonable request as deemed appropriate by their Line Manager to support business needs. Specific responsibilities and authorities are defined in procedures relevant to the role.

In return we offer competitive rates of pay, 25 days holiday plus Bank holidays rising to 30 with length of service, 5% Company pension contributions, Company sick pay, career development opportunities, Employee Assistance Programme and Cycle to Work Scheme.

[Employer hidden — view at passion-project.co.uk] is committed to being an equal opportunities employer and values diversity.

Process Validation Engineer

Swansea

Feb 12, 2025

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