Inspire us with your knowledge, skills & experience and in return for we can offer you the following when joining our expanding Validation team.

• The chance to work with the cell and gene therapy world leader in lentiviral vector technology.
• Development of your skills and experience within fill finish isolation technologies at our new facility.
• The opportunity to grow, lead and coach an Aseptic Validation specialist sub team.

As a result of growth we are increasing our manufacturing and development capabilities which include the addition of new fill finish facilities which need aseptic processing/’steriles’ Validation expertise.

Oxford BioMedica is a pioneering cell and gene therapy company and our work is helping to deliver life changing treatments.

As our expert you will be:

• Creating and maintaining validation master plans, schedules to ensure that all equipment, facilities, utilities 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 (equipment, facilities, utilities,) to meet defined timelines
• Generating, reviewing, executing 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 have:

• A bachelor’s degree in a relevant scientific, engineering or related discipline
• Proven experience as a validation specialist and/or senior validation specialist roles gained within GMP secondary manufacturing environments in biopharmaceuticals or pharmaceuticals sectors
• Experience within aseptic processing and/or ‘fill & finish’ environments
• 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 written & spoken English communications essential.

We look forward to receiving your application.

No agencies please.