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.
- 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 email@example.com.