CSV Engineer

7 days ago

Waterford, Waterford, Ireland Tandem Project Management Ltd. Full time

Summary:
A CSV Engineer is required for a biopharmaceutical company in Waterford. The incumbent will ensure the ongoing validation compliance of computerised equipment and systems onsite.

Responsibilities:

  • Integrally involved in the validation of all new computerised equipment, and control systems onsite.
  • Generates validation documentation (protocols/reports) and helps with the execution of protocols for computerised equipment and systems.
  • Participates in the change control process advising on CSV issues, as appropriate.
  • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
  • Ensures projects are managed in compliance with all required Sanofi and legal requirements (Health & Safety, cGMP, construction, environmental etc).
  • Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
  • Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation.
  • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  • Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
  • Generate/review/approve execution of the validation/revalidation plans.
  • Review and approval of site change controls.
  • Ensure compliance to cGMP at all times.

Qualifications & Experience:

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
  • 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector and 2-3 years' experience in validation environment.
  • Project management experience.
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Competent technical knowledge of pharmaceutical plants.
  • Knowledge of requirements for of GAMP, ISPE Baseline guides.
  • Full understanding of relevant quality and compliance regulations.
  • Good knowledge of quality management systems.
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