Value Stream Recipe Owner
- Employer
- CSL Behring
- Location
- Kankakee, Illinois
- Start date
- Jun 17, 2021
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical, Operations
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest
Job Details
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.
Responsibilities include:
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 subject matter expert for 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
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.
This position reports to: Regional Head of Execution Systems or Value Stream Recipe Owner Lead
Principal Accountabilities: .
1
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.
2
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.
3
Participates in the creation of the Execution System validation strategy together with the Global and Site CSV & Quality representatives and ensure strong contribution to 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
4
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.
5
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.
Education:
Bachelor of Science in an Engineering or other Science discipline/Masters preferred, Computer Science, or Management Information Systems.
Related Experience:
5 years' practical 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
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.
Experience in Process Excellence methodology is desirable, but not required.
Special Training:
Must have demonstrated capability for technical leading of complex DCS/PCS /Automation projects with integrated MES systems initial development through validation of the facility
Company
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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