Cleaning Validation Specialist
This vacancy has now expired
Located within a commutable distance of one of Ireland’s international airports, this position would suit both local candidates and those wishing to commute from outside of Ireland.
Who are we looking for?
We are looking for a Cleaning Validation Specialist with biotech experience to join this new project for a period of 9 months initially.
- Develop, author, and maintain the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility.
- Develop and implement cleaning strategies for fixed and mobile parts.
- Development and/or optimize 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.
- Author and review process transfer documentation, cleaning risk assessments, technical protocols and reports, cleaning validation documents and supporting documentation as required.
- Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained.
- Identify and implement improvements where feasible.
- Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to media/buffer preparation. Temporary shift working may be required during periods of engineering batch and validation batch execution.
- Provide on the floor support for troubleshooting cleaning related issues and to lead manufacturing investigations into process deviations.
- Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
- Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
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