Cleaning Validation Specialist

Summary:

Our client is a biopharmaceutical company based in Cork looking for a Senior Cleaning Validation Specialist to provide validation, primarily cleaning cycle development and cleaning validation and technical support to their vaccines team.

Responsibilities: Execute cleaning cycle development, cleaning validation and PQ of equipment. Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports. Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments. Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards. Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines. Technical report writing, statistical analysis of data. Adherence to the latest regulatory guidelines. Provide technical input and support and present as an SME on relevant topics during regulatory inspections. Adherence to highest standards for Compliance (Quality and Safety). Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical input to risk assessments, audits, regulatory inspections and incident investigations. Ensure the highest Quality, Compliance and Safety standards by participating and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. Qualifications & Experience: B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field. 3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering. A working knowledge of the GxP systems associated with this role would be advantageous, these include, but are not limited to: GLIMS and eVAL, electronic batch records.


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