Oxford BioMedica (UK) Limited

Validation Specialist

05 Dec 2018
31 Jan 2019
R & D , Scientific

Key Responsibilities:

  • Supporting the validation of OXB’s equipment, facilities, utilities and processes in accordance with GMP requirements and a lifecycle approach in coordination with multi-functional Validation Working Parties at OXB, liaising with internal functions including Engineering, Manufacturing, QC, QA and Manufacturing  Development. This includes:
  • 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)
  • Managing the provision of validation services with third party providers (including directing, instructing and supervising OEM technicians/fitters and contractors as required) to qualify/requalify specialist equipment
  • 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 all relevant records and schedules
  • Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the ‘validated state’ to support the company’s validation efforts
  • Maintaining qualification related records, procedures, documents and drawings
  • Maintaining Validation Master Plans (VMPs) and inventories of GMP critical computerized systems & software ensuring that all such systems are in compliance with Eudralex Volume 4, annex 11 & FDA 21CFR Part 11
  • Represent the Validation Department during client audits and regulatory inspections
  • Ensuring compliance with safety, health and environmental (SHE) legislation
  • Provide validation support to the continuous improvement, company’s expansion & automation projects at OXB in an environment of rapid change
  • Contribute to proactive management of asset preservation, energy reduction initiatives etc.
  • Any other task required from time to time to assist the efficient running of the Company’s business
  • The successful candidate for this Validation Specialist position will have:
  • Degree (or equivalent) in Science / Engineering or related discipline
  • Broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP
  • Demonstrable validation experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ)
  • Understanding and experience of biopharmaceutical and/or pharmaceutical process validation. Experience of aseptic processing and cleanrooms highly desirable
  • Computerised systems validation (CSV) experience desirable
  • Project management methodology approach to work organisation and delivery

Person Specification:

  • Excellent interpersonal and influence skills with an ability to interface well at all levels both within the organisation and with clients and manufacturers.
  • Good time management skills
  • Effective communication/presentation skills
  • Facilitation skills
  • Problem solving skills and a continuous improvement mindset
  • Ability to learn quickly and think laterally
  • Ability to work independently and with the multi-professional team
  • Demonstrable ability to prioritise workload in order to meet deadlines
  • Commitment to achieving personal, departmental and organisational objectives
  • Willingness to travel and work off site at alternative contract / external sites
  • Flexible to meet changing service requirements

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

Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.

*no agencies please*

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