Pharmaceutical Manufacturing Specialist
2 weeks ago
We are recruiting for a Cleaning Validation Specialist to join our team in Dublin. Located 15 minutes from Dublin Airport, this leading organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility.
Job Description:- Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance manufacturing facility.
- Develop and implement/update cleaning strategies for fixed and mobile parts.
- Develop/update and/or optimise cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
- Generate and execute cleaning validation protocols as required.
- Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
- 2+ years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organisation.
- Technical and operational knowledge of cleaning validation/verification, quality systems, and regulatory requirements across multiple health authorities.
- Experience of cleaning validation.
- Experience of cleaning verification/validation of downstream processing equipment.
If you have the necessary skills and experience, please get in touch with us today.
Key Skills:Cleaning Validation, Quality Systems, Regulatory Requirements, Pharmaceutical Manufacturing
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