Validation Engineer

4 weeks ago

Cork, Cork, Ireland DPS Group Global Full time
Overview

Validation Engineer - Kerry

An opportunity is now available for a Validation Engineer with duties to include

  • Review of all IOQ documentation generated by C&Q vendor.
  • Preparation, execution and summary reports from PQ stage onwards for a full suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, Warehousing.
  • Support and review of documentation from Calibrations and Thermal Mapping Vendors.

Responsibilities:

  • Evaluation of validation requirements including areas of new equipment, change controls, new requirements.
  • Monitor status of projects and get updates where required, from a validation perspective.
  • Provide support to ensure that validation status reports are maintained through the issuing of monthly reports and regular validation group meetings.
  • Liaise with project managers to ensure project schedule is adhered to.
  • Assessment of current practices to ensure compliance with cGMP requirements.
  • Review/Implementation of procedures, reports, results etc. for compliance.
  • Review/ Implementation of both global and AICL, CSV documentation.
  • Responsible for the coordination of SDLC Documentation.
  • Review and approval of all project's validation protocols plant wide.
  • Review and approval of project change controls.
  • Provide input into the development of company validation standards.

Arcadis | DPS Group is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.


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