Cleaning Validation Specialist

3 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

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:
  1. Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance manufacturing facility.
  2. Develop and implement/update cleaning strategies for fixed and mobile parts.
  3. 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.
  4. 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.
  5. Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required.
About you:
  1. 2 + years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organisation.
  2. Technical and operational knowledge of cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
  3. Experience of cleaning validation.
  4. 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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