Process Technical Specialist

  • Contract
  • Cork

TPM04765

Summary:
Our client is a bio pharmaceutical company based in Cork looking for a technical support to their Vaccines Operations to support the technology transfer and filing requirements for Vaccines Operations manufacture.

Responsibilities:

  • Facilitate running of activities (e.g. support batch manufacture and licence submissions) in the Vaccines Operations value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines Operations.
  • Delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.
  • Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities.
  • Responsible for the technical transfer and scale–up of a new process into Vaccines Operations.
  • Input into Technical planning and decisions for the Vaccines operations, to ensure supply of high quality product through tactical planning and execution of production schedules.
  • Technical Review, ownership of and approval of Global Change management records as required.
  • 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.
  • 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 Technology Transfer for Vaccines Operations.

Qualifications & Experience:

  • Degree in Chemical or process engineer.
  • 3 to 5 years’ experience in a GMP manufacturing environment.
  • Experience in Lean 6 Sigma tools an advantage.

To apply for this job email your details to orla.daly@tandemprm.ie.