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Cleaning validation sme

Dublin
Tandem Project Management Limited
Cleaner
Posted: 6 July
Offer description

Summary: We are currently seeking an experienced Cleaning Validation Specialist for our client, a biopharmaceutical company based in Dublin, to join a new project team on a short term contract to drive the development and implementation of a robust sampling and dispensing operation within their new facility. Responsibilities: Ensuring the highest standards of cleanliness and compliance, supporting both operational readiness and regulatory expectations. Developing and implementing the cleaning strategy for equipment and areas used in the sampling and dispensing of raw materials and small molecule APIs. Designing and executing cleaning process development studies and associated risk assessments. Writing and reviewing cleaning validation and verification protocols, reports, and supporting documentation in accordance with cGMP and company standards. Supporting the qualification and commissioning of new equipment and utilities related to sampling and dispensing operations. Collaborating with cross-functional teams including Engineering, QA, QC, Manufacturing, and Regulatory Affairs. Staying abreast of regulatory guidelines and industry best practices for cleaning validation. Qualifications & Experience: A degree in a scientific or engineering discipline (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences). Proven industry experience in cleaning validation/verification, particularly in equipment used for raw material handling or small molecule API manufacturing. Strong knowledge of cGMP, FDA, EMA, and ICH guidelines as they relate to cleaning validation. Experience authoring validation protocols and reports. Excellent problem-solving, documentation, and communication skills.

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