Are you an MES Engineer with over 5 years' experience in an aseptic pharmaceutical environment?
- Development, configuration, and testing of Master Batch Records (MBRs) from initial to the final design.
- Leading 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 MES system in the 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.
- Equipment integration design, configuration, and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server
- Contribute to and assist with Corporate, FDA, IMB Auditors, and other regulatory bodies during company audits.
- 3rd level degree in Engineering or Science
- Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing
- Knowledge of regulation requirements (GMP & EH&S)
- 5+years of experience in an aseptic pharmaceutical environment.
- Broad technical experience in MES systems.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie
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