A Cleaning Validation Technical Specialist is required by a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The Cleaning Validation Technical Specialist will be responsible for:
o Implementing cleaning strategies for fixed and mobile parts per Cleaning Validation Master Plan and associated strategies.
o 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 where applicable.
o Generate and execute cleaning validation protocols, plans and reports as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable and representative cleaning sampling activities.
o Work closely with colleagues within the Technical Services team, and with Quality Assurance, Quality Control, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of start up, technology transfer, and routine manufacturing timelines in the context of cleaning validation.
The Cleaning Validation Technical Specialist will require:
o Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
o Minimum 2 years’ experience in Cleaning verification/validation / Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance or drug product manufacturing organization.
If you would like to hear more about this Cleaning Validation Technical Specialist role, then please contact Kathy at LSC on 021-4777329 or apply directly through this advert.