Validation Engineer

Summary:

The Role
The Validation Engineer is responsible to co-ordination & execution validation activities associated with the qualification of new process equipment, set-up of new production lines and introduction of new products in support of increased commercial demands.

Role & Responsibilities

• Lead projects to deliver new products into existing and new product families.
• Working as part of a cross-functional project team, the engineer will be responsible for the following process validation related activities;
• Development of validation strategy
• Estimation of validation timelines & resource requirements
• Generation & approval of the Master Validation Plan & Report
• Work closely with Lean and Operations teams to ensure that any new processes developed meet world class manufacturing standards.
• Ensure that complete and effective validations are carried out on all processes before transferring to manufacture.
• Design and introduce manufacturing processes for new products to increase capabilities and efficiencies delivering a competitive edge to our client and their customers.
• Manage a variable workload and multiple projects to deliver to customer expectations and drive future revenue.
• Generation & approval of validation protocols & reports
• Development of a robust & efficient validation test plan to support build planning
  
  Experience Required
• Relevant third level qualification in Science or Engineering
• A minimum of 3 years working in a relevant medical device manufacturing environment.
• Practical experience & good working knowledge of Technology transfer / product on-load experience would be an advantage
• Automation of processes by working with equipment vendors and internal automation team.

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