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Principal Validation Specialist

Job Title: Principal Validation Specialist
Contract Type: Permanent
Location: Cork
REF: 93398
Job Published: 3 months ago

Job Description

Contact: Deirdre Finnerty
Telephone: 086 3073779
Principal Validation Specialist Job In Cork
Our client, a Pharmaceutical device company in Cork are currently looking to recruit a Principal Validation Specialist Job for their site.
Primary activities/responsibilities:
  • Lead and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).
  • Lead and close process related deviations and reports.
  • Protocol/report authoring/execution/oversight/approval as appropriate
  • Ensure highest Quality, Compliance and Safety standards.
  • Participate and comply with the Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.
  • Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
  • Recommend technical approaches in line with global and local standards.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Author/approve Change controls and MIDAS documents as appropriate.
  • Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology)
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.
  • > 4 years’ experience in a similar role in a manufacturing environment. Ideally in a senior role.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical operation (e.g. manufacturing, technology, validation, engineering, quality, analytical)
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations, with experience of successfully delivering a significant process / technical project
Skill Set
  • Demonstrated process, qualification and technology SME background within the pharmaceutical or Biopharmaceutical industry.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.
  • Demonstrated leadership, including change management skills with a continuous improvement focus
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated high level of problem solving and facilitation skills.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
For further information on this Principal Validation Specialist Job role in Cork please contact Deirdre Finnerty on 086 3073779 /
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