(15h Left) Project Engineer
7 days ago
Our client, a leading pharmaceutical manufacturing company based in Co. Kerry, is seeking a CQV Engineer (Lyophiliser) to join their team. The successful candidate will be responsible for commissioning, qualification, and validation (CQV) activities associated with lyophilisation systems and related utilities in a GMP manufacturing environment.
Responsibilities
Lead and execute CQV activities for lyophilisation systems, including process equipment, utilities, and supporting systems.
Develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols, in line with cGMP and internal quality standards.
Ensure adherence to project schedules by coordinating and executing commissioning and validation tasks within agreed timelines.
Work cross‑functionally with Engineering, Quality, and Manufacturing teams to ensure alignment on CQV scope and objectives.
Participate in risk assessments and support the development of validation strategies for lyophiliser and associated systems.
Review vendor documentation and ensure compliance with design specifications and regulatory expectations.
Support deviation investigations, change controls, and CAPAs associated with CQV activities.
Ensure validation data is accurately recorded and maintained in accordance with GDP and site documentation standards.
Participate in system handover processes and ensure validated systems are ready for operational use.
Support continuous improvement initiatives within the CQV function to enhance efficiency and compliance.
Qualifications & Experience
Bachelor’s degree in Engineering, Science, or a related discipline.
Minimum of 5 years’ experience in a CQV or Validation role within a GMP‑regulated pharmaceutical or biopharmaceutical environment.
Strong experience with lyophilisation systems and related utilities.
Excellent understanding of CQV principles, validation lifecycle management, and regulatory requirements (FDA, EMA, ISPE, GAMP 5).
Experience preparing and executing validation documentation for complex systems.
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