17475-Validation/Technical Specialist-Cork Contractor

This is an 11-month contract.

Purpose:

This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation, and Technical activities for Vaccine 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 Vaccine IPT.

 Responsibilities:

• Ensure the 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 Qualifications & Requirements:

• 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.
• Working and collaborating across multiple functional teams.
• Change management skills