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Validation Specialist Isolator validation focus

Job LocationMerseyside
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Validation SpecialistBased in LiverpoolHigher than average rate - call for details*** PAYE or Umbrella only ***Pharmaceutical industry6 month contract initiallyDue to a new package of work being introduced to this multinational pharmaceutical company they require an additional person to work in their Validation team at Specialist level with a focus on VHP (Vapour Hydrogen Peroxide) Isolator validation as part of the installation of a new Isolator for QC Sterility testing. As the Isolator is also being installed within a new room any Facilities or HVAC Validation experience would be highly desirable.Duties:To provide technical leadership and to co-ordinate the activities of validation work as required within the sterile manufacturing area; specifically manage the validation activities of the installation of the new Isolator within a new room to include HVAC and / or Facilities validation activities.The role holder will be required to monitor ongoing validation exercises and provide regular updates on progress, communicating possible issues that may affect timelines and milestones. The role holder is required to write and execute validation protocols following ICH guidelines and other organisational standards; to promptly write reports on completion of execution of the validation/verification studies. The role holder will be required to actively make recommendations following successful or unsuccessful validation or technical studies. Also to actively be involved in continuous improvement so that measurable benefits are delivered as a result of continuous improvement activities.Qualifications and Experience:

  • Strong cGMP background in the Biological or Pharmaceutical industry
  • Experience of sterile manufacturing
  • Have experience in the validation of VHP Isolators in a Sterile manufacturing cGMP environment. Experience in the validation of Isolators within a fill finish environment will also be considered as its very similar experience.
  • Previous experience of generating and executing IQ, OQ, PQ on GMP equipment.
  • Previous CSV and IT systems experience is desirable.
  • For further details and to apply please contact Johnathan Miller at Scantec via johnathanm (at) scantec. co. ukScantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis. Agency PAYE, Umbrella and CIS (if applicable) engagement models are also available, which will result in a different pay rate than advertised above.Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website. Required skills
  • Isolator Validation
  • Keyskills :
    Isolat Validation

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