Senior Validation Engineer

30 Sep 2019

Senior Validation Opportunity with a leading Bio-pharma company based in Cork

We are currently working with a bio-pharmaceutical company who are based in Cork and are looking for an experienced Validation engineer to join their team. This is a permanent opportunity and the successful individual will help lead the Facilities, Utilities and Equipment Validation work stream from the front.

Key requirements:

  • Extensive understanding and application of validation principles, concepts, practices, and standards.
  • Knowledge of RBV, proven experience of FUE Qualification- a distinct advantage.
  • Proficient in current Good Manufacturing Practices (GMPs).
  • Full working knowledge of equipment and systems.
  • Strong verbal, written, and interpersonal communication skills are required.
  • Investigation and report writing skills.
  • Specific Education & Experience Requirements:
    • 3-5 years of relevant experience and bachelor's degree in science or related field.

General Job Responsibilities:

  • Generation, review and approval of all validation life-cycle documentation and maintain master plans and SOPs pertaining to validation.
  • Generation of System Periodic Reviews
  • Deviation, change control assessment & technical support for routine manufacturing operations.
  • Technical and Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities
  • Coaching & development of junior team members with proactive engagement in Goals/Objectives, 1:1, IDPs
  • Participate in the governance of work stream projects, scheduling and delivery of activities in accordance with program timelines.
  • Articulation of technical issues and investigation outcomes to senior management.
  • Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
  • May also investigate and trouble-shoot problems which occur, and determine solutions.
  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.

If you are a dynamic, resilient and process orientated individual and you are looking for you next challenge then get in touch today or click the 'apply now' button below.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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