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 processes
• Responsible 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 Quality
• Ensure 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.

• 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 Maintenance
• Proven expertise in aseptic operations, analytical testing, process development and tech transfer.
• Experience with lyophilized products advantageous
• Experience in start-up facility advantageous
• Experience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management.