Value Stream Recipe Owner Lead (Base Fractionation)
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.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Primarily accountable for the implementation, maintenance and ownership of the PCS/MES and PLC process recipes related to the specific value stream.
- Adherence to the global strategy & scope by maintaining/delivering/implementing the required process control within the DCS, PCS, MES and PLC systems for both new and legacy systems.
- Alignment of the system with the Global Execution Systems approach within Manufacturing Operations.
- Technical project ownership for all Execution Systems related project deliverables including oversight & review of contractors/integrators work during design, construction, commissioning, and validation phases of CAPEX projects & OPEX initiatives & changes
- The resource planning and assignment of the Value Stream Recipe Owners under his responsibilities
- Ownership of the process recipe and configuration across the MES, PCS, and/or PLC systems
- 24/7 and/or on-call Manufacturing support of the facilities with the goal of maximizing facility uptime.
- Incident tracking, remediation and improvement associated with the assigned Value Stream
This scope will also include aligning and coordinating the definition of the required hardware with the Platform Owner; including the development of the software, and system coordination with the required project schedule to enable Commissioning and Validation of the Process Systems to meet the overall project schedule aligned to GAMP 5. Further, to coordinate interfaces with the Data Historian, Data Acquisition Systems, Building Management Systems, Central Alarm Management System, Manufacturing Control Network, and Enterprise applications.
The role will be responsible to implement modifications related to the process improvements, changes, support, and maintenance of the systems.
- Aligns and reviews deliverables from the different execution system work packages as a Recipe Lead. Ensures the right technical prioritization on project activities. Works closely together with respective Project Managers to ensure deliverables are ready in time for the different milestones throughout the project. Works closely together with the work package owner of Library and Standards to ensure the defined standards are followed consistently throughout the project and the library modules are used as intended.
- Ensure the overall recipe design and implementation meets Engineering and Manufacturing requirements for the operation of the plant.
- Responsible for ensuring an understanding of the current Manufacturing processes within the value stream, working in collaboration with the value stream network.
- Responsible for Value Stream Recipe Owner resource management including assigning resources to daily activities (operations) and supporting project activities based on the Site Projects & Operations Portfolio.
- Specific employee related activities include, talent acquisition, training, career development, providing coaching, performance management (IPM) and compensation. Additionally, as a result of the matrix environment, may support resources from other functional areas.
- Writes & reviews Process system documentation as defined by the project. Participates in the creation & testing of software. Troubleshoots and corrects as needed.
- Perform Project Manager Role on an interim basis. Ensuring that project work is completed within budget and on schedule and in accordance with the project management methodology as defined in QMS
- Installation and configuration to the ISA-S88/S95 standard following Project phases: Requirements definition, detailed design generation, software configuration, system integration and Qualification testing.
- Participates in the creation of the Execution System validation strategy together with the Global and Site CSV & Quality representatives and be the primary point of contact for audit inspection.
- Responsible for ES investigations and CAPAs.
- Collaborates with other disciplines across the project to ensure overall coordination of the tasks and consistency in execution strategies.
- Seeks opportunities for optimization of the design, programming and test activities within the Execution System scope.
- Responsible for ownership of change management associated with Equipment and Processes on the Execution Systems with engagement with the global value stream recipe owner
- Develop validation test cases and perform testing
- Supports the coordination of the work (at various stages of the Project, i.e.: design, commissioning, qualification, validation, and start-up) with the other automation engineers to balance workload across the group.
- Interfaces with customer groups on the project to ensure we are designing, executing, and delivering to in accordance to Global Engineering Procedures and Execution Systems standards, including Quality, Facilities, Engineering, MFG, and EHS&S. This will include building strong relationships with the customer base and helping them set the proper expectations for project delivery.
- Bachelor of Science in an Engineering or other Science discipline/Masters preferred, Computer Science, or Management Information Systems.
- 8 years' practical leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems/Automation; 5 years or more working experience in Execution Systems/Automation design and support
- Considerable knowledge in the lifecycle manufacturing process (preferably in the related value stream)
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).
- Hands on experience in Recipe and Workflow Authoring (e.g.: Base Fractionation, Mfg., Packaging) and on experience in configuring master data and equipment in MES.
- Direct experience designing, building, deploying and supporting automation and execution systems in a regulated large-scale process-based manufacturing environment.
- Experience in running site-based shop floor systems in a globally distributed footprint is highly desirable.
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
- Ability to build, mentor and grow a high performing and cohesive team. Experience in Process Excellence methodology is desirable, but not required.
Must have demonstrated capability for technical leading of complex DCS/PCS /Automation projects with integrated MES systems initial development through validation of the facility