SimoTech requires an MES Engineer for a Biotech project in Dublin. Candidates must have at least 5+ years’ experience in operations/manufacturing environment in the pharmaceutical / life sciences industry.
- Responsible for the development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design.
- Responsible for leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions.
- Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing.
- Responsible for liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner.
- Responsible for support and updates to Recipe Control system.
- Responsible for the MBR design oversight, support and ongoing development of the Manufacturing Execution System (MES) system.
- Responsible for training of Electronic Batch Record (EBR) designers and end-users on MES integration activities and development of job aids.
- Responsible for support and to assist in fast MES issue resolution where required and as directed by Operations leadership.
- Responsible for the development, review and update MES Standard Operating Procedures and Design Specifications.
- Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities for MES integration removing paper from the execution and review process to reduce cycle times.
- Support implementation of process changes Responsible to perform all activities in compliance with safety standards and site safety procedures.
Qualification and Experience
- Bachelors in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
- Minimum of 5+ years’ experience in operations/manufacturing environment.
- Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing.
- Knowledge of regulation requirements (including cGMP, 21CFR Part11).
- Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA).
- MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries.
- Strong capabilities in S95 level 2 and level 3 systems and their integration.
- Strong working knowledge of OLE for Process Control.
- Experience of Supervisory Control and Data Acquisition (SCADA), Process Control Systems (PCS), Recipe Managers – Siemens, Rockwell, Kepware OPC Server, OSI Pi, RT Reports, OSI PI Asset Framework, Laboratory benchtop equipment, Learning Management Systems.
- Strong exposure to MES technologies, including automated data collection, historian applications (OSI PI), visualization, quality and efficiency in manufacturing.
- MES experience in implementing stable and scalable solutions for
- Continuous Data Retrieval from Level 2 and Level 3 systems.
- Creation / Loading of Level 2 Recipes.
- Retrieval of Alarms and Events (Batch Context Information) into MES for Annotation, Review and Trending.
- Strong PL/SQL programming experience in software development with Microsoft Visual Studio / Development tools; knowledge of web services, ASP and .net technologies.
- Strong SQL experience with exposure to both Oracle & SQL Server databases along with Crystal Reports.
- Strong attention to details, including the ability to proof read documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.