Engineering , Science, Pharmaceutical & Food

Validation Engineer

  • Contract
  • Remote
  • Greater London
  • 41937662

PE Global are looking for a Validation Engineer (Associate/Junior level) to support ongoing projects for a leading Animal Health GMP regulated multinational company based in Walton, Buckinghamshire.

 

The Associate Validation Specialist role is set within the Validation Department, part of the Engineering function.

 

 

Key Responsibilities

 

  • Developing and executing validation plans for projects and modifications to processes, equipment, utilities, computer systems and facilities.
  • Ensuring adherence to the requalification plan to maintain compliance.
  • Writing, reviewing and approving validation protocols, SOPs and other documentation.
  • Raising and completing CAPAs and deviations; supporting investigations into events as required.
  • Providing technical input into gap assessments, Product Quality Reviews and Quality Risk Assessments.
  • Participating in asset reliability reviews.
  • Any other works, as required, to support the Validation and Engineering teams.

 

Key Skills:

  • Demonstrated experience of varied validation and requalification activities such as:
  • Autoclaves
  • HVAC, including HEPA filter testing
  • Clean rooms, Isolators, biological safety cabinets, fume hoods and downflow booths
  • Airflow visualization studies
  • Vessels, pipework and sterile components
  • Manufacturing processes
  • Software, including spreadsheets
  • Cleaning (CIP, parts washers and manual cleaning processes)
  • Utilities (including steam, compressed air, nitrogen, purified water, water for injection)
  • Laboratory test methods
  • Controlled temperature units (including fridges, freezers, incubators, cold rooms)
  • Computerised systems
  • Experience of using various validation equipment items, such as Kaye validators and Valprobes, Yokogawa data loggers, DOP testing equipment, anemometers, and balometers.
  • Understanding of cGMP, including good documentation practices
  • Attention to detail, ability to review and correct technical documentation
  • Good knowledge of standard PC applications, particularly Microsoft Word and Excel.

 

 

Required Experience

  • BSc or MSc in a Science or Engineering related discipline
  • A minimum of 2 years working in a validation, quality, production or engineering role within the pharmaceutical industry.
  • Management of external contractors

 

 

If interested in applying to this job opportunity, please don’t hesitate to call +44  20 3966 9800 or alternatively send an updated CV to conor.dolan@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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