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Validation Engineer

Therese Keohane
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Job Reference: JO-2008-65324_1596730720


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.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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