Validation Engineer for GMP Manufacturing
3 days ago
LSC offers a unique contract opportunity for a Validation Engineer to join a pioneering Biopharmaceutical company in Ireland.
This state-of-the-art manufacturing facility produces a range of products across various therapeutic areas, including oncology, autoimmunity, pneumonia, and infectious disease.
- Design, develop, review, approve, and execute qualification/validation documentation and cycle development studies in accordance with the standard approval process.
- Implement change controls while addressing technical issues during study execution.
- Engage with Production, Maintenance, and Quality representatives during Cycle Development & Performance Qualification activities.
- Contribute to quality notifications through investigation authoring/reviewing/approval.
To succeed in this role, you will require:
- Experience in cleaning validation, encompassing CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimization, cleaning verification, cleanability, and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
- Significant experience in a comparable role, working as an individual contributor in a GMP manufacturing setting, with relevant qualifications/skills, such as Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, achieving excellence.
- Effective exception/deviation management and change control.
The successful candidate will possess knowledge and experience in the following areas, which will be beneficial:
- Filter validation CCI qualification shipping qualification equipment periodic validation isolator VHP/HVAC qualification controlled temperature units
Equipment Qualification Note: Please note that this is a contract opportunity, and you must hold a Stamp 1G/Stamp 4 visa to apply.
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