Validation Engineer

  • Sligo
  • Team Horizon
Team Horizon is seeking a Validation Engineer on a permanent basis for our client’s manufacturing facility in the Northwest. Why you should apply: * You will get the opportunity to coordinate, implement and actively participate in the site Validation Program and general Technical Operations activities * Attractive Salary & Benefits Package on offer – Bonus, Healthcare,Pension as well as excellent career progression opportunities What you will be doing: * Coordination / direction and active participation in the validation of site Facility, equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. * Generation/maintenance/execution of the Site Validation Master Plan, Project Validation Plans and schedules * Generation of validation protocols and final reports to cGMP standards. * Generation of validation investigations and implementation of corrective actions. * Creation, review and approval of various quality documents and test data. * Management of validation exception events and change control processes. * Maintenance and tracking of validation equipment, if applicable. * Performing cross training within the team and training of new team members. * Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. * Communicating with peers and management regarding activities in the area, including elevation of events or concerns. What you need to apply: * Qualification and/or degree in engineering or scientific discipline. * 3 years plus validation experience in pharmaceutical, diagnostics or medical device industry & knowledge of cGMP and regulatory requirements * Strong communication (written and oral), presentation and troubleshooting skills required. * Effective interpersonal and organizational skills