MES Integration Engineer

at  SimoTech

ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

QUALIFICATIONS

• Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries.
• Knowledge of regulation requirements (including cGMP and 21CFR Part11).
• Knowledge of quality systems (e.g. CCMS, EDMQ, NC/CAPA).
• Knowledge of validation processes and understanding of validation protocol generation requirements.
• Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, SCADA, PLC, Historian).
• Prior MES experience with focus on workflow, S95 & S88 batch standards and integration from the control layer to MES in pharma and biopharma industries.
• Good understanding of S95 Level 2 and Level 3 systems and their integration.
• Have strong exposure to MES technologies, including automated data collection, Historian applications (OSI PI), visualisation, 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, and retrieval of alarms and events (batch context information) into MES for annotation, review, and trending.
• Strong SQL experience, with exposure to both Oracle & SQL server databases along with Crystal Reports.
• Strong attention to detail, including the ability to proofread documents, and to accurately translate customers’ requirements into meaningful end-user instructions consistently.Excellent organisational and communication (verbal and written) skills at all levels of the organisation.

• Development, configuration, and testing of integration components of Master Batch Records (MBRs) from initial to final design.
• Support the integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions.
• Equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing.
• Liaising with plant support, system owners, and Operations teams regarding documentation changes, in an effective and timely manner.
• Responsible for the MBR design oversight, support and ongoing development of the client site MES system.
• Training of Electronic Batch Record (EBR) Designers and end-users on MES integration activities and development of job aids.
• Support and assist in fast Manufacturing Execution System (MES) issue resolution where required, and as directed, by Operations leadership.
• Develop, review and update MES Standard Operating Procedures and design specifications.