Headcount Solutions is sourcing a Manufacturing Specialist (MES) for our client’s biotech facility in Dublin. This person will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
· Development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
· Lead MBR development design reviews including liaising with Operations, Process Development and Quality functions.
· Drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
· Support and ongoing development of the MES system in development of MBRs and improving the MES business process.
· Training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
· Development, review and update of MES Standard Operating Procedures.
· Preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.
· Accountable for adherence to established timelines and metrics for the change control and CAPA process.
· Any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment – OSI PI, Recipe Managers – Siemens, Rockwell, Kepware OPC Server.
· Resolving interface errors and stock discrepancies between ERP/MES as required.
· Providing technical support where required and as directed by Operations leadership.
· Bachelor’s degree in Engineering or Science.
· 5+ years experience in an aseptic pharmaceutical environment.
· Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing.
· Knowledge of regulation requirements (GMP & EH&S).
· Advantageous to possess experience of working in syringe/Vial manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.