Process Automation Engineer - Data Historian (all genders)
Process Automation Engineer – Data Historian (all genders) | Toulouse, France
Just-Evotec Biologics is seeking a motivated and creative Process Automation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The Process Automation Engineer will be part of the Process Engineering team in the Manufacturing Science and Technology (MSAT) department. The incumbent will serve as the site-level system owner for the data historian system. In this role, the incumbent will serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site data historian for use in clinical and commercial manufacturing at the Toulouse J.POD manufacturing facility. The successful candidate will have demonstrated proficiency in data historian deployment and system administration, integration of with related business and automation systems including, but not limited to, DeltaV process control system (DCS/SCADA), MES, Building Management Systems (BMS), etc. Experience working in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is required.
Serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site data historian.
Collaborate with site and global teams for the development and implementation of the data historian system life cycle strategy and business/technical processes. Leverage existing solutions and develop further enhancements of the data historian solution for J.POD manufacturing as a platform and ensure alignment across the J.POD manufacturing network.
Maintain compliance with company standards for active directory, network configuration and cybersecurity.
Collaborate with the validation team for the initial and ongoing qualification of the PAS system and the equipment it controls. Ensure full regulatory compliance including requirements for GMPs and data integrity.
Develop interfaces and integration solutions to collect data from various sources within the manufacturing environment, including, but not limited to DeltaV PAS, PAS-X MES, BMS systems, and other process equipment and systems. Implement data mapping, cleansing, and transformation processes to ensure accurate and reliable data storage and retrieval in AVEVA PI.
Configure and administer the AVEVA PI System, including the creation and management of tags, data archives, and security settings. Monitor system performance, troubleshoot issues, and optimize system configurations to ensure high availability and data integrity.
Design and develop intuitive and insightful data visualization and reporting solutions using AVEVA PI (OSI PI) tools (e.g., PI Vision, PI ProcessBook). Collaborate with stakeholders to define key performance indicators (KPIs), develop dashboards, and generate reports to support data-driven decision-making and operational performance monitoring.
Develop business processes, guidelines, SOPs, and training for the PI system. Provide training and knowledge transfer sessions to end-users and stakeholders on the data historian system, data visualization tools, and best practices
Develop and implement data historian system updates via the quality system change control process to support introduction of new manufacturing equipment, manufacturing process
Manage the system to deliver optimal performance and reliability for process systems and equipment to support commercial manufacturing operations.
Provide on-demand technical support including troubleshooting and issue resolution related to data historian system infrastructure, configuration and interfaces to support manufacturing operational requirements.
Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
Provide project oversight on data historian implementation projects contracted to vendors or 3rd party suppliers/integrators.
Bachelors degree or higher in a relevant field (Engineering, Computer Science, or related discipline). Advanced degrees or certifications related to the AVEVA PI System (OSI PI system) are preferred
Minimum of 7 years of experience working with the AVEVA PI system within the pharmaceutical sector
Working knowledge of cGMP manufacturing and regulatory regulations and requirements (FDA CFR 21 Part 11 and EMA Annex 11) for biologics/pharmaceuticals
Deep understanding of AVEVA PI architecture, data modeling, and system configuration best practices
Proficiency in developing interfaces and integrating OSI PI with various data sources and systems (e.g., SCADA/DCS, LIMS, MES, ERP, BMS)
Expertise in data visualization and reporting tools, such as PI Vision, PI ProcessBook, and Microsoft Power BI
Demonstrated ability as a self-starter to work independently and collaboratively on cross-functional teams
Excellent analytical and problem-solving abilities, with a keen eye for detail. Ability to analyse complex data sets, identify trends
Verbal and written communications skills in both English and French
Additional Preferred Qualifications:
Previous experience in computer software validation coordinating activities with IT, QA, Warehouse, and Manufacturing
Leverage expertise using GAMP5 guidelines for risk-based approach to computer system validation
Applies knowledge and expertise to solve complex technical problems
Authority inspection or audit support involvement
Experience with single-use technologies and systems
DeltaV PAS experience
Koerber-Werum PAS-X experience
Proficiency developing and executing CSV plans and protocols
About Just-Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just-Evotec Biologics team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. This position will be located at our newly built state-of-the-art labs and J.POD® commercial manufacturing facility in Toulouse.
For job opportunities, learn more at www.evotec.com/en/career
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.