Validation Specialist

We’re working with a client developing some of the most innovative future therapies in precision medicine. Fast growing and profitable the company has a hugely inclusive culture and focuses on developing people and providing excellent career opportunities on top of a strong ethos around work / life balance. In short, it’s a great place to be and a great place to grow.

This role takes responsibility for:

  • Providing regular reports to management on the status of facility and equipment maintenance, servicing, calibration and validation tasks.
  • Provide training to staff on facility and equipment procedures.
  • To coordinate PAT testing on equipment.
  • To be the Principal User (PU) on assigned major items of equipment (including facility HVAC and other systems).
  • Preparation and execution of validation protocols.
  • Maintenance of the validation schedule and facility regulatory compliance.
  • Performance of routine qualification, calibration and maintenance of equipment.
  • Complete and review quality related documentation including but not limited to validation documents, change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures.
  • Preparation, approval and maintenance of Standard Operating Procedures.
  • Ensure that confidentiality of all information relating to clients and patients is always maintained.
  • Communicate procedures and results with clients.
  • Demonstrate excellent customer service skills for both internal and external customers.
  • Plan and undertake the Validation of new equipment and to advise and assist others in this.
  • Compliance with all Health and Safety policies and procedures.
  • Providing out of hours cover for critical equipment alarms as required on a rotational basis.
  • Contribute to the set up and execution the validation schedule for the new facility.
  • Ensuring data integrity of software systems.