Oxford BioMedica (UK) Limited

Validation Specialist(s)

Location
Oxford
Salary
Competitive
Posted
01 Feb 2021
Closes
01 Mar 2021
Ref
OXB-VAL-20-301
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

The Oxford Biomedica Validation Team work across GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are appropriately addressed.  This environment provides our Validation Specialists with vast opportunities to gain experience, allowing them to grow and prosper with us.

Our preference is to hire in experience professionals within the biopharma research and manufacturing however we are able to consider applications from other equipment, facilities and CSV validation professionals from similar aseptic and clean room environments who would be interested to cross train into this field.

Your responsibilities in this role would be:

  • Supporting the validation of OXB’s equipment, facilities, utilities and processes in accordance with GMP requirements
  • Supporting system owners in preparing user requirement specifications (URS), conducting design qualification (DQ) studies and system/equipment selection
  • Preparing and maintaining validation plans (VPs), assisting system owners with impact assessments and identifying validation requirements
  • Executing validation protocols (equipment, facilities, utilities, computerised systems and processes)
  • Critically reviewing the results of validation studies and effectively managing/closing-out any deviations
  • Generating validation reports before handover/return to system owner and updating the relevant systems/schedules
  • Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the ‘validated state’

To be successful in this role, you will have the following skills and experience:

  • A Degree (or equivalent) in a Science / Engineering or related discipline
  • A working knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of equipment/systems, facilities, utilities and processes.
  • Demonstrable experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation/execution of lifecycle documents (URS, DQ, IQ, OQ & PQ )in a biopharmaceutical, pharmaceutical or related industry
  • Understanding and experience of aseptic processing and cleanroom technologies highly desirable

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

No Agencies please