Engineering , Science, Pharmaceutical & Food

Tech Specialist’ Validation

  • Contract
  • Remote
  • Munster
  • 41947532

PE is currently recruiting for a Tech Specialist’ Validation on behalf of our client based in Cork. This is an initial 11-month contract position.

 

Role:

  • This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture.
  • The Validation/Technical Specialist will be required to collaborate across function teams on site on the requalification of utilities and equipment, support cleaning validation activities and support Vaccine batch manufacturing where appropriate.
  • The successful candidate is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.
  • 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 IPT.
  • Support team continuous process improvement initiatives.
  • Participate in problem solving teams across all areas of the Vaccine IPT

Requirements:

  • Minimum 6 months 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 (Delta V knowledge preferable but not essential)
  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.
  • Problem solving skills.
  • Working and collaboration across multiple functional teams.
  • Change management skills.

Qualifications:

  • Honors Degree or Masters in a Science or Engineering discipline

 

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