Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
As a result of growth we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment, IT systems and processes. We are therefore able to offer opportunities to Senior Validation Specialists to join our team and focus within their field of validation expertise.
As an expert you will be:
Creating and maintaining validation master plans, schedules to ensure that our enterprise wide computer systems are maintained in a qualified state to support GMP requirements
Assisting system owners with system/equipment URS and DQ documents and uses a risk-based approach to determine the appropriate validation requirements
Creating, reviewing, approving and executing validation plans and protocols (computerised systems) to meet defined timelines
Generating, reviewing and approving validation reports in a timely manner on completion of validation activities
Managing validation reviews, re-qualifications and revalidations to ensure maintenance of the ‘validated state’ and ongoing GMP compliance
Demonstrating and fostering a culture of continuous improvement in support of the business aims/objectives and identifies, investigates and implements efficient, effective and compliant ways of working.
To be our expert you will need:
Bachelor’s degree in a relevant scientific, engineering or related discipline
Proven experience as a CSV Validation Specialist and/or Senior Validation Specialist roles gained within GMP manufacturing/analytical environments in biopharmaceuticals or pharmaceuticals sectors preferred
Strong team-orientation with a proven ability to coach/mentor and lead less experienced members of the validation team in project-related activities
Proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills, to deliver results within predefined timescales
Excellent spoken English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams.