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CQV Engineer

  1. Midlands (Ireland)
Limerick
  1. Contract
Competitive
  1. CAPEX Projects
09-08-2024
34779

This vacancy has now expired

CQV Engineer - Pharmacueticlas - 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 (JDs Attached):
  • Generates, executes, reviews qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.  
  • 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.
  • Co-ordination with cross function for: interdependent tasks, decision making, timely escalations on quality events/project delays, safety etc.,
  • Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Capability to work as independent contributor as well as team tasks.
  • Well versed with safety practices at site.
  • Trains/advises less experienced specialists and technicians.
  •  Assesses quality system documentation for completeness and accuracy, and dispositions documentation per SOPs.
  • Manages projects and prepares status reports.
  • Familiarity with equipment in QC, manufacturing (drug substance-Especially MAbs), AHU, Facilities, utilities
  • Basic familiarity with paperless validation tool like ValGenesis
  • Working to expert level knowledge in 21 CFR part 1 1, Computerized system, PLC/HMI/SCADA systems, Audit trail etc.,
  • Familiarity with deliverables minimum but not limited to:
  • URS, DQ, IQ, OQ, IOQ, Commissioning Protocol Traceability Matrix, Summary Reports, Turn Over Package, SOP, 21 CFR part 1 1 assessment, Data integrity assessments, Protocol change controls/Deviations etc., System Life cycle documents.
 

Must Have’s to successfully fill this position.
  • Education and Experience: Requires a BS/BA in Engineering, Chemistry, or Life Sciences with related experience within the field; will substitute relevant experience for education.
  • Qualification/validation experience required.
  • Well versed with Microsoft tools like: Word, .xls, .ppt etc.,

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

 #LI-CH3
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