We're currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Key Responsibilities:Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.Coordinate technical deliverables within Drug Substance to support the successful product launch.Provide technical support to the operations team's during commercial manufacturing.Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.Support Batch Disposition activities by providing SME technical support for comment resolution.Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.Education & Experience Requirements:Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six SigmaExperience in a risk-based approach to manufacturing through use of tools such as FMEAIf interested in this posting please feel free to contact Seán McCarthy on or for further information.