With operations in 35+ nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
LES Lab Support Lead - EU/APAC (m/f/d)
In this role you collaborate with LES Lab Support Lead US to formulate and implement a strategy for the global support of LES within the QC labs at Seqirus and CSL Behring, engaging global business partners in QC. You build and maintain a global team at each site for the delivery of application roadmap objectives and BAU activities. Also you create global LES procedures that provide the framework for each site to perform duties associated with lab qualification and compliance activities in accordance with industry best practices, global regulatory standards, and GxP regulations. In this role you are responsible for a team of individuals of the LES Laboratory Support group located at Seqirus and CSL Behring Quality Control sites. You are accountable for the teams who manage lab systems at the Liverpool, Amsterdam, Marburg, Bern and Parkville sites.
You report directly to the Head – Laboratory Execution Systems.
As Manufacturing Data Systems Lead you work in a global role and you are accountable for the lifecycle management of the manufacturing process data collection, management, and reporting infrastructure, including its ongoing evolution.
Also you are accountable for developing the process historian system, batch reporting systems, and analytical systems to enable the start-up, commissioning, validation and maintenance of large-scale manufacturing facilities.
The role includes developing a strategy for progressing execution systems to align with the Recipe Driven Execution (RDE) approach of controlling the process and information systems within the manufacturing operation.
In detail, your responsibilities include:
- Manufacture Data Systems (PI, PAT, SynTQ, InfoBatch, SIMCA-online, Topview) and interface systems (PCS, MES, Statistica, Manufacturing, and Lab Data platforms)
- Align the scope definition of systems requirements with the equipment vendors
- Develop the software and system in alignment to support the commissioning and validation of the manufacturing process data to meet the overall project schedule
- Coordinate interfaces with integrated systems, including MES, Building Management, Data Acquisition, and Manufacturing Control Network
- Global System Owner & administration of Data Historian Systems (OSI-PI)
- Accountable for the effective development and implementation of innovation and continuous improvement within Execution Systems
- Drive the exploration and adoption of new tools and techniques and propose improvements to the data pipeline. Integrate the operations data platform with the Data Scientist workbench, the Data Marketplace, and Analytic Tools such as Tableau, Spotfire, R, and others
- Provide architectural oversight for processes that perform data transformation, metadata extraction, workload management, and error processing management
- Leverage best practices for dashboard and data visualization to make key decisions and drive business results
- Increase and maintain OSIsoft PI Data Historian data collection to support manufacturing areas and new projects
- Create the Data Integration Roadmap and Data Operations Strategy
- Develop extract, transform, and load (“ETL”) procedures from multiple data sources as needed
- Lead the design and planning to implement standardized, automated operational and quality control processes to deliver accurate and timely data and reporting to meet or exceed SLAs
- Design and develop dimensional data models to support the Operational Technology application layer
- Develop reports and maintain existing reports to support manufacturing, validation, QA, and engineering using Data Systems Report
- Data historian integration with control systems and MES. System support and troubleshooting as required
- Collaborate with Data Architects, Business SME’s, and Data Scientists to architect data products and services
- Elicit requirements from a wide range of different teams. Evaluate needs against existing data sources
- Lead end-user training sessions for OSIsoft PI Coresight, PI Datalink, and Ocean Data Systems Dream Report
Who you are:
As part of a team that owns PCS/MES/BMS data, this is a critical technical role with an excellent opportunity for you if you have a strong balance of technical skills, time management, and soft skills.
The below competencies furthermore contribute to your success:
- University degree in Engineering, Computer Sciences, or similar field
- 7+ years of practical leadership experience in the pharmaceutical industry, including expertise in manufacturing, engineering, or information systems
- Experience with OSI-PI and OPC administration, support, maintenance and licensing
- Experience with Spotfire, Tableau, and Power BI, Visualization, and Reporting
- Experience and understanding of Industry 4.0 domains: Internet Of Things, Systems Integration, Cyber Security, Simulation (Digital Twins), and Cloud Computing
- Experience in cGMPs and manufacturing operations in FDA regulated facility
- Experience or exposure to Machine Learning and Artificial Intelligence a plus
- Experience using ALM platforms such as QC Vera and Codebeamer
- OSI Soft Accredited in Administrator and Developer Learning Path (desirable)
- Excellent understanding of PI Architecture and critical components. Highly competent in implementing, configuring, and troubleshooting of OSI PI Interfaces including but not limited to OPC DA, PI to PI, RDBMS, UFL, EMDVB, and SIS Batch
- Knowledge of SCADA, PLC, OPC, Continuous/Batch Historians, MES systems, and DCS Based control systems, including network topology concepts
- Knowledge of CSV, CMC, and regulatory submission requirements
- Knowledge of SQL and general database concepts
- Proficient in project management principles and project lifecycle phases