CSV Validation Technologist - Pharma/Biotech

Opus Recruitment Solutions Ltd
West Wickham
£34500 - £42500 per annum
13 Nov 2017
15 Nov 2017
Contract Type
Full Time
A Pharmaceutical company in the South West of England are seeking a CSV Validation Technologist Senior Process Validation Specialist to join their team on a permanent basis.

This is an excellent organisation who manufacture unique products & retain staff well due to the fantastic working environment!

You will lead CSV validation on investigational studies in support of Medicinal products, regulatory inspections & the provision of technical customer support.

Some of the duties & responsibilities include:
  • Lead the site as subject matter expert to ensure Computer Systems Validation activities are undertaken in accordance with the Validation Master Plan, Validation Policy and Process Validation procedure.
  • Write, review & approve CSV validation protocols prior to execution
  • Coordinate with stakeholders the completion of validation studies, managing expectations and meeting targets
  • Assess Change control documentation to determine change impact with respect to the validation status
  • To lead CSV discussions during audits
  • To support operational areas in the implementation of change
  • To ensure stakeholder expectations are managed and projects are delivered to current GMP standards.
  • To ensure the completion of deviations and the closure of CAPAs
Candidates must have the following skills and experience:
  • Degree in Science or Engineering or equivalent & ideally an academic achievement
  • Must have significant CSV experience
  • Understanding of data integrity
  • Biotechnology experience is highly advantageous
  • Must have an understanding of the validation life cycle
  • Project management experience
  • Line management experience including coordinated cross functional teams
  • Ideal to have experience with the evaluation of statistical data

If you are interested in applying and learning more about the role, please send an updated CV with an overview of your experience & notice period or availability to start a new role.

This job was originally posted as www.cwjobs.co.uk/job/77509520