Cleaning Validation Specialist
2 weeks ago
Cleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - Dublin
Are you looking for the chance to join a life-changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Cleaning Validation Specialist for a 12-month contract based in Dublin.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology in their one-of-a-kind manufacturing facility.
Cleaning Validation Specialist Responsibilities:- 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.
- Development/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.
- Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required.
- 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.
Are you a good fit for this Cleaning Validation Specialist position? Get in touch with us today.
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