· Initiate, co-ordinate and complete assigned projects within the engineering department, using structured approach and detailed planning to deliver projects that meet or exceed stakeholder expectations and that are delivered Right First Time, safely, on schedule and within budget.
· Complete Process / Product Validations within the department as they arise, in conjunction with Quality/Validation group.
· Support Equipment Validations within the department as they arise, in conjunction with Quality/Validation group.
· Conduct process feasibility trials / process DOE's to determine appropriate/robust process windows.
· Prepare & execute OQ / PQ protocols for process / material changes as needed.
· Work in conjunction with the Quality & Validation group to determine appropriate validation sampling and acceptance criteria.
· Liaise with operations and technician group to prepare plan for validation builds.
· Co-ordinate the execution of OQ / PQ builds.
· Prepare OQ / PQ validation reports and deviations as required.
· Conduct process capability analysis using Minitab.
· Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
· Lead and coordinate the troubleshooting of various manufacturing process issues.
· Responsible for dealing with process, product and quality issues to achieve long term solutions.
· Regular reporting of manufacturing process performance to relevant personnel. Use of OEE line performance tools to identify and address efficiency losses.
· Degree in Mechanical / Production Engineering or equivalent.
· Minimum of 3 years relevant experience, preferably within Medical Device industry or other regulated environments.
· Working knowledge of Product & Process validations essential.
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