An MES Engineer is required to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
As MES Engineer you will be:
o Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
o Responsible for leading MBR development design reviews including liaising with Operations, Process
o Responsible for drafting , executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design
o Responsible for the support and ongoing development of the site MES system in development of MBRs and improving the MES business process.
o Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, o Responsible for production support to assist in fast Manufacturing Execution System (MES) issue resolution, including presence in the production suite and also during non-standard shifts
As MES Engineer you will have:
o Bachelor degree in Science, Engineering, IT or the equivalent combination of experience and education
o Typically 3-5 years of MES related experience in highly regulated GMP environments
o Working knowledge of solid dosage manufacturing and packaging; parenterals in pharmaceutical/biotech industries or aseptic processing
o Knowledge of regulation requirements (including cGMP, 21CFR Part11)
o Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA)
o Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, QMTS, EDMQ)
o MES experience with focus on workflow, S95 & S88 standards & integration from the control layer to ERP via MES.
For full details on this role please contact Kathy on 021 4777329 or apply directly through this advert.