Client urgently needs an experienced systems architect with hands on experience with MES, SCADA, PLC, systems in a pharmecutical manufacturing environment. Preferred qualifications and skills include
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)
* 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)
* Practical knowledge in continuous improvement tools and methodologies
* 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
o Continuous Data Retrieval from Level 2 and Level 3 systems
o Creation / Loading of Level 2 Recipes
o 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
* Excellent organizational and communication (verbal and written) skills at all levels of the organization
Please note: As this is a contract role, no sponsorship of work permits is possible.