Validation Engineer

  • Contract
  • Cork

Website TPM04565

Summary:
Our client is a global bio pharmaceutical company based in Cork, looking for a Validation Engineer to join their team. The successful candidate will be responsible for requalification of utilities and equipment, support cleaning validation activities and support of vaccine batch manufacturing.

Responsibilities:

  • Accountable for supporting all technical components to deliver an effective and efficient Vaccines Operations.
  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Validation Protocol/report authoring/execution/oversight/approval as appropriate.
  • Support cleaning validation activities.
  • Support manufacturing investigations and corrective actions as appropriate.
  • Support input into batch records where changes are led by the Technical Operations.
  • Support team continuous process improvement initiatives.
  • Participate in problem solving teams across all areas of the Vaccine Operations.

Qualifications & Experience:

  • Honours Degree or Masters in a Science or Engineering discipline.
  • Minimum 1/2 years’ experience in a regulated manufacturing environment.
  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical).
  • Demonstrated delivery of a section of a process / technical project.
  • Understanding of temperature mapping activities, requalification requirements of equipment, periodic reviews of equipment.
  • Knowledge and understanding of the requirements around sanitization and sterilization processes.
  • Some automation (DeltaV knowledge preferable but not essential).
  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.

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