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.