Brookfield

CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader, motivated by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America's Best Employers for 2022 by Forbes magazine.

The Associate Director, Manufacturing Data Systems is a global role accountable for the strategy, implementation, and lifecycle management of the manufacturing process data collection, historization, analysis, and reporting applications and infrastructure, in support of the evolving advanced process analytics strategy within CSL. As part of a team that owns PCS/MES/BMS data, this is a critical technical and global leadership role with an excellent opportunity for someone who has a strong balance of technical leadership, organizational leadership, and communication skills.

Accountable for developing and implementing the global strategy for the process data historization systems, reporting systems, and advanced process analytical systems to enable the start-up, commissioning, validation, maintenance, and continued process understanding and improvement of large-scale manufacturing facilities. This requires international travel up to 50% to the different manufacturing facilities (Kankakee, Illinois; Marburg, Germany; Bern, Switzerland; Broadmeadows, Australia)

The scope includes developing and implementing a strategy for progressing CSL execution systems platforms to align with the Recipe Driven Execution (RDE) approach of controlling the process and information systems within the manufacturing operation, and enabling advanced process data analytics capabilities globally. 

The scope will also include:

• Assuming overall system ownership responsibilities for Manufacturing Data Systems (PI, PAT, SynTQ, InfoBatch, SIMCA-online, Topview) and interfacing of those MDS Systems with other plant floor and analytical systems (PCS, MES, Statistica, Manufacturing, and Lab Data platforms).
• Aligning the scope definition of systems requirements with the equipment vendors.
• Developing the software and systems in alignment to support the commissioning and validation of the manufacturing process data to meet the overall project schedules.
• Coordinating interfaces with integrated systems, including MES, Building Management, Data Acquisition, and Manufacturing Control Network.
• Global System ownership and administration of Data Historian Systems (OSI-PI) and advanced process analytics systems.

This position reports to: Execution Systems Lead, Process and Operations Technology

Reports to this position: Manufacturing Data Systems Regional Leads (US, EU, and APAC)

Responsibilities:

1. 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 in the advanced process data analytics space. Develop, implement, and manage a strategy for the effective use of process data historization and analysis systems, to support the CSL advanced process analytics strategy.
• Leverage best practices and drive end user adoption (for process data dashboard and data visualizations to monitor and make key operational decisions, to support capacity, process improvement, and Right First Time initiatives. 
• Oversee the implementation and maintenance of OSIsoft PI Data Historian data collection to support manufacturing areas and new projects, in direct support of capacity, process improvement, and Right First Time initiatives
• Create and implement the Data Integration Roadmap and Data Operations Strategy.
• Ensure the global OSI Pi Program meets all meets all schedule and budgetary commitments, and is executed efficiently and according to plan

2. Accountable for efficient processes:

• 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.
• Oversee the development and lifecycle of reports to support manufacturing, validation (including Continual Process Validation), QA, and engineering using Data Systems reporting functionality.
• Data historian integration with control systems and MES. System support and troubleshooting as required in support of ongoing, 24/7 operations

3. Coordinate with key stakeholders and business partners:

• Collaborate with IT Business SMEs, 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.
• Ensure the global OSI Pi Program meets all stakeholder requirements. Key stakeholders include Manufacturing Value Stream leads, Process Engineering, Site Quality leads. Ongoing communication to stakeholders, including on-site “roadshows” to increase awareness of the program, is essential. 

Qualifications:

• Minimum a Bachelor's in Engineering (Chemical preferred) or Applied Science , or equivalent experience. 
• 8+ years of practical technical and organizationalleadership experience in the pharmaceutical industry, including expertise in manufacturing, engineering, and information systems.
• Direct experience with OSI-PI Administration and Support, OPC Server administration, maintenance and licensing
• Deep technical understanding and practical experience with advanced process analytics systems used within the pharmaceutical industry.
• Direct experience with the implementation and change management associated with applications for advanced process analytics, such as SIMCA , Statistica, SIPAT
• Direct, operational experience in cGMPs and manufacturing operations in FDA/EMEA/SwissMedic regulated facilities, including regulatory audit preparation and leadership participation
• Demonstrated experience in leading and managing global orgainizations.
• Demonstrated experience in managing large global CAPEX projects. 
• OSI Soft Accredited in Administrator and Developer Learning Path (desirable).

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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