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GMP Validation Engineer

1 week ago

Sligo, Sligo, Ireland Cpl Healthcare Full time

Cpl Healthcare is looking for an experienced GMP Validation Engineer (Process Development) to support our pharmaceutical and biopharmaceutical clients and suppliers. The successful candidate will be responsible for providing thermal mapping, process development, and validation support.

This position offers a dynamic work environment and the opportunity to collaborate on innovative projects within the industry. The core function of this role will be to provide technical and scientific expertise to both the organisation's team and their customers.

Responsibilities:

  • Coordinate and execute cycle development and performance qualification studies on upstream and/or downstream process equipment including autoclaves, GMP washers, bioreactors, process skids, and vessels.
  • Analyse cycle performance data, troubleshoot issues, and implement improvements where necessary.
  • Collaborate with cross-functional teams including Quality Assurance, Engineering, and Production to support ongoing sterilisation and washing needs, and assisting with deviation and exception resolution.
  • Liaise with internal & supplier SME's where necessary.
  • Responsible for the execution of routine (PQ) & cycle development temperature mapping on the same equipment.
  • Analysing, interpretation, and reporting on validation testing against acceptance criteria.
  • Execute particular validation documentation including protocols, qualification reports, summary reports, procedures, and other lifecycle documents.
  • Ensuring GDP is adhered to.
  • Calibrating thermocouples and performing post-study calibration verifications.
  • Derivation of process-specific documents from standard template design.
  • Engage & communicate task progress and actions through meetings, presentations, and reports to management, customers & suppliers.
  • Staying up to date with industry trends, regulatory changes, and advancements in sterilisation/washing technology.
  • Together with our SME's, provide technical expertise on autoclave cycle development and sterilisation & washing principles.
  • Test equipment management.
  • Due to the nature of this work, extended stays at Customer location are expected.
  • Supporting other C&Q work and team as required.
  • Ensuring that safety procedures are adhered to at all times.
  • At all times this person needs to reflect the company's goals and values.