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Senior Validation Specialist, Aseptic Fill/Finish

35 / per week - Full-Time
Oxford Business Park ,

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.


Benefits Summary

  • Competitive pension scheme     
  • Generous holiday entitlement
  • Private Health Care
  • Health Cashback Plan
  • Employee Assistance Plan (EAP)              
  • Life Assurance
  • Childcare Vouchers
  • Discount Portal
  • Discretionary Share Option Scheme
  • Discretionary Sharesave Scheme
  • Cycle To Work Scheme
  • Public Transport Season Ticket Loans

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