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CSV Engineer

  1. Midlands (Ireland)
County Limerick
  1. Contract
Competitive
  1. CAPEX Projects
09-05-2024
34157
CSV Engineer - Limerick, Ireland - 12-Month Contract 

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.


Role Summary:
  • Prepares/reviews validation documentation related to projects/change controls.
  • Manages change controls and other compliance related tasks e.g. non-conformances.
  • Participates in the review of current and future CSV procedures and polices Analyses the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Participates in regulatory audits and communicates company’s computer validation policies.
  • Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
  • Manages projects and prepares status reports using Microsoft project and other communication tools.
  •  


Requirements: 
  • Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
  • Experience in a GMP environment essential.
  • Biologics experience highly desirable.

If this role is of interest to you, please apply now! 


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