Lab Technical Services Specialist

  • Contract
  • Cork

Website TPM04805

Summary:
Our client is a bio pharmaceutical company based in Cork , looking for a Technical Specialist to provide support to the Lab Ops Technical projects group.

Responsibilities:

  • Provide Technical Support for the commissioning and qualification of laboratory equipment including equipment IOQ and PQ.
  • Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
  • Author, review and approve manufacturing documentation associated with transferred processes.
  • Troubleshoot technical issues and lead investigations through scientific problem-solving approaches.
  • Partner with quality groups to support change management to implement process improvements.
  • Generate study plans, protocols and summary reports.
  • Establish and lead implementation the continued process verification program to effectively manage product life cycles.
  • Adherence to highest standards for Compliance (Quality and Safety).
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
  • Actively participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.
  • 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.

Qualifications & Experience:

  • B.Sc. Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
  • 3+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.
  • Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
  • Evidence of Continuous Professional Development and cross skilling.

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