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

• Hands-on experience in GMP-regulated environments, with strong knowledge of cGMP, 21 CFR Part 11, and quality systems (EDMQ, CCMS, NC/CAPA).
• Proficiency in MES, ERP, SCADA, PLC, and Historian systems, with a focus on S95 & S88 standards. Knowledge of PAS-X MES and OSI PI preferred.
• Experience in Level 2 and Level 3 systems integration, including MES-to-control layer connectivity.
• Hands-on experience with systems integration, OSI PI AF/EF, Kepware OPC, and OPC protocols.
• Familiarity with SCADA and Process Control (PCS) systems, Recipe Managers (Siemens, Rockwell, Kepware, OSI PI), learning management systems, and laboratory equipment integration.
• Ability to implement scalable MES solutions for data retrieval, recipe management, and alarm/event tracking.
• Strong PL/SQL expertise, with experience in Oracle, SQL Server, Crystal Reports, and .NET technologies.
• Understanding of validation processes, protocol generation, and adherence to good documentation practices.
• Strong attention to detail, ability to translate requirements into clear documentation, and effective stakeholder engagement and communication skills.

• Qualification of PAS-X MES adaptors to communicate with Automation endpoints. Develop, configure, and test integration components for Master Batch Records (MBRs), from concept to final design.
• Support integration development design reviews collaborating with Automation, Operations, Process Development, Quality, and Validation teams.
• Design, configure and test equipment integration solution, enabling seamless interaction between MBRs, shop floor equipment, and laboratory instruments.
• Coordinate with Plant Support, System Owners, and Operations teams to ensure timely and effective documentation updates.
• Provide support and updates for the in-house Recipe Control system.
• Responsible for the MBR design oversight, support and ongoing development of the site MES system.
• Train Electronic Batch Record (EBR) designers and end-users on MES integration activities, including the development of job aids.
• Troubleshoot and resolve MES-related issues, supporting fast resolution as directed by Operations leadership.
• Develop, review and update MES Standard Operating Procedures and design specifications.
• Develop, review, and update MES Standard Operating Procedures (SOPs) and Design Specifications.
• Drive continuous improvement in MES solutions, collaborating with internal teams and vendor consultants.