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Biopharmaceutical Validation Professional
1 week ago
LSC, Life Science Consultants seeks a skilled Validation Engineer III to join a global Biopharmaceutical company in Carlow. The successful candidate will have extensive experience in cleaning validation, equipment periodic validation, and change control.
They will design and execute qualification/validation documentation and cycle development studies, develop and implement change controls, and resolve technical issues during study execution. They will also engage with production, maintenance, and quality representatives during Cycle Development & Performance Qualification activities.
Requirements:
- Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
- Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
- Exception / Deviation Management and Change Control.
