Engineering , Science, Pharmaceutical & Food
Tech Specialist’ Validation
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.
- 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
- 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.
- Honors Degree or Masters in a Science or Engineering discipline