Technical Specialist-Vaccine Technical

  • Cork
  • Contract 2 year
  • JO-1811-64036_1550835438

Summary

Technical Specialist - Vaccine Technical, Vaccine IPT- (Contract role up until end of 2020)
The Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT.

RESPONSIBILITIES

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical activities but relating to all activities
  • Input into Technical planning and decisions for the Vaccine IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
  • Lead and close process related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).
  • Protocol/report authoring/execution/oversight/approval as appropriate
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Cleaning validation activities, Periodic reviews, Requalification of equipment
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
  • Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant.
  • Responsible for supporting a culture of Continuous Improvement by championing Six Sigma tools within Technical Group for Vaccines IPT
  • Model the Leadership behaviours and understand the principles to drive a culture of continuous improvement building a High Performance Organisation

REQUIREMENTS

  • Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology). 3 years'+ experience in biopharmaceutical/vaccines environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
  • Experience in Validation activities e.g. Cleaning Validation, Requalification
  • Experience with assessing material changes would be an advantage
  • 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

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