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 support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.Responsible for process ownership, demonstrating technical excellence as the subject matter expert for drug product processesResponsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.Responsible for technology transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities.Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and QualityEnsure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.Responsible for participation in creating, sharing, and adopting best practices and business process strategies.Education & Experience Requirements:Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or MaintenanceProven expertise in aseptic operations, analytical testing, process development and tech transfer.Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirableExperience with lyophilized products advantageousExperience in start-up facility advantageousExperience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management.If interested in this posting please feel free to contact Seán McCarthy on or for further information.