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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Operational Excellence Technical Specialist


Reference:AMC21774 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Operational Excellence Lead

      Operational Excellence Technical Specialist
      11 month contract
      Cork
        AMC21774


        We are currently on the lookout for an experienced Operational Excellence Technical Specialist for a global biotechnology manufacturer based in Cork. If you have 5+ years experience in a similar role and are ready for your next challenge this could be the role for you!


      Requirements
      • Over 5 years experience in biopharmaceutical, pharmaceutical or medical device industry including operational excellence projects
      • B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
      • Project management experiences in wide-scaled and/or complex project.
      • Lean six sigma qualification and experience applying these principles
      • Strong analytical and problem-solving skills
      The role
      • Support the process by wholistically reviewing the how and why individual process steps are performed, identifying areas where efficiencies can be made, and leading projects to deliver these efficiencies
      • Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
      • Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols.
      • Managing EHS and Quality investigations and overseeing batch record reviews.
      • Provide technical support to Operation functions and changes.
      • Apply Lean Six Sigma and Lean methodologies.
      • Represent the department on cross-functional project teams.
      • Adherence to highest standards for Compliance (Quality and Safety).
      • Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
      • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.