LSC have a great contract opportunity for a Cleaning Validation Technical Specialist to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have minimum 5 years’ experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Maintain/update input to the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility at College Park Dublin.
o Develop and implement/update cleaning strategies for fixed and mobile parts.
o Development/update 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.
o 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 to occur.
o Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of startup, technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
o Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous.
o Experience of cleaning verification/validation of downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels).
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Cleaning Validation Technical Specialist opportunity!