3 Days Left Cleaning Validation Specialist

2 weeks ago

Dublin, Dublin City, Ireland Tandem Project Management Limited Full time

Summary: Our client is a biopharmaceutical company based in Dublin looking for a Cleaning Validation Technical Specialist you will play a key role in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at their facility in Dublin. Responsibilities: Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments. Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction. Provide support for the technical services team during regulatory agency inspections. Identify operational process improvements using Lean Tools Assist with the investigation of and operations deviations through the eQMS system, engaging with all relevant personnel and functions as appropriate. Participating in technical projects, inclusive of process optimisation projects. Responsibility for Change Management and Deviation Management. Qualifications & Experience: Degree qualification in science or engineering discipline. Minimum of three years experience in cleaning validation, preferably in bulk drug substance manufacturing. Experience in lean processing is an advantage. Experience in preparation of routine documentation to GMP standard Experience working with digital tools and applications (MS Office, Adobe etc) Ability to read, comprehend and prepare applicable documentation required Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities. Knowledge of downstream purification processes such as ultrafiltration is desirable. Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.

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