Execution Systems, Head of Standards and Governance
- Employer
- CSL - Australia
- Location
- Broadmeadows, AU
- Salary
- Competitive
- Start date
- 7 May 2022
- Closing date
- 26 May 2022
View more
- Discipline
- Information Technology
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
The key responsibilities of this position are:
Principal Accountabilities
1. Responsible for the development of ES Standards that support all platforms that enable recipe-driven execution (RDE) across E2E Operations for all manufacturing sites to support all batch processing activities from lab to patient. Supports implementation of these Standards across the manufacturing network as the champion for the utilization of standards. Owns the governance of Execution System standards and acts as gatekeeper for library changes. Continuously monitors adherence to the standards and identify opportunities for improvement
This also includes ownership of ES recipe libraries, recipe management, process control, and data historian activities related to batch production, testing and release. Develop and maintain a road map of current and future Execution Systems, aligned with the developed standards.
2. Responsible to develop global standards for all ES Architecture to implement RDE. In addition, provide plant level ES support of the Platform Owners across all CSL Sites. The position holder will be taking ownership of and contributing to the development of plant technology strategies and plans. Also responsible for contributing to the uptime & maintenance of a functional, reliable, and cost-effective platform environment for the assigned areas. Support continuous improvement in identifying potential improvements across all Execution Systems platforms.
3. Responsible for the development & implementation of a global CSV standard to support both Execution Systems (ES) and Laboratory Execution Systems (LES). This will include being accountable for developing and executing the global Computerized System Validation (CSV) strategy for control systems within ES, LES, and interfaces. This role will be accountable for the CSV scope across all CAPEX projects & programs across multiple sites to ensure CSV strategy and roles & responsibilities between global and local functions are clear and in compliance with health and regulatory authorities. In addition, this role will maintain all validated ES/LES systems in a compliant status.
4. Responsible for the development & implementation of a global manufacturing data systems strategy. Accountable for the lifecycle management of the manufacturing process data collection, management, and reporting infrastructure. This role owns the process historian system, batch reporting systems, and analytical systems to enable the start-up, commissioning, validation, and maintenance of large-scale manufacturing facilities across E2E Operations.
5. Responsible to ensure ES/LES takes technical lead role on the global deployment of Data Integrity across E2E Operations.
Position Requirements
Education:
Related Experience:
Special Training:
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.
Do work that matters at CSL Behring!
- Globally develop, own, and implement:
- Execution Systems Standards including supporting Governance model
- Execution Systems architecture & interfaces with I&T enterprise applications.
- CSV strategy across all Execution Systems & Laboratory Execution Systems platforms.
- Manufacturing Data Systems/Data Historian strategy & systems.
- Act as SME for all Data Integrity initiatives across E2E Operations
Principal Accountabilities
1. Responsible for the development of ES Standards that support all platforms that enable recipe-driven execution (RDE) across E2E Operations for all manufacturing sites to support all batch processing activities from lab to patient. Supports implementation of these Standards across the manufacturing network as the champion for the utilization of standards. Owns the governance of Execution System standards and acts as gatekeeper for library changes. Continuously monitors adherence to the standards and identify opportunities for improvement
This also includes ownership of ES recipe libraries, recipe management, process control, and data historian activities related to batch production, testing and release. Develop and maintain a road map of current and future Execution Systems, aligned with the developed standards.
2. Responsible to develop global standards for all ES Architecture to implement RDE. In addition, provide plant level ES support of the Platform Owners across all CSL Sites. The position holder will be taking ownership of and contributing to the development of plant technology strategies and plans. Also responsible for contributing to the uptime & maintenance of a functional, reliable, and cost-effective platform environment for the assigned areas. Support continuous improvement in identifying potential improvements across all Execution Systems platforms.
3. Responsible for the development & implementation of a global CSV standard to support both Execution Systems (ES) and Laboratory Execution Systems (LES). This will include being accountable for developing and executing the global Computerized System Validation (CSV) strategy for control systems within ES, LES, and interfaces. This role will be accountable for the CSV scope across all CAPEX projects & programs across multiple sites to ensure CSV strategy and roles & responsibilities between global and local functions are clear and in compliance with health and regulatory authorities. In addition, this role will maintain all validated ES/LES systems in a compliant status.
4. Responsible for the development & implementation of a global manufacturing data systems strategy. Accountable for the lifecycle management of the manufacturing process data collection, management, and reporting infrastructure. This role owns the process historian system, batch reporting systems, and analytical systems to enable the start-up, commissioning, validation, and maintenance of large-scale manufacturing facilities across E2E Operations.
5. Responsible to ensure ES/LES takes technical lead role on the global deployment of Data Integrity across E2E Operations.
Position Requirements
Education:
- Bachelor of Science in an Engineering or other Science discipline, Computer Science, or Management Information Systems.
Related Experience:
- 10+ years' work experience, with at least 5 years' experience in GMP execution systems
- Specific experience in process automation, MES, and batch manufacturing industry standards (ISA S88 &S95)
- Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, MES, PCS, PAT, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment
- Demonstrated ability to influence through clear, concise and impactful verbal and written communication skills
- Experience in Process Excellence methodology is desirable, but not required.
Special Training:
- Ability to work across a range of countries and cultures
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.
Do work that matters at CSL Behring!
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