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!
This position will provide technical leadership in PCS and MES automation for the Kankakee site including requirements gathering, technical proposals, system design and development of complex PCS and MES solutions. The incumbent will contribute to integration of PLC systems, HMI packages, SCADA systems, Distributed Control systems, Manufacturing Exectuion Systems, Visual Basic and PC networking technology, system architecture design, development of electronic procedures, documentation, training, and integration with local and enterprise systems.
- 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
- Ownership of the process recipe and configuration across the MES, PCS, and/or PLC systems
- Incident tracking, remediation and improvement associated with the assigned Value Stream
Principal Accountabilities: Itemize the separate duties and responsibilities of the position. Fully detail each major task or responsibility necessary to correctly perform the position function. The tasks are ranked from those most crucial in the beginning of the section to those, which are more routine in the end of the section.
- Design automation, electrical, and control panel solutions incorporating NEC, NFPA and PSM standards in electrical power / distribution.
- Responsible for ensuring an understanding of the current Manufacturing processes, working in collaboration with the manufacturing team.
- Installation and configuration aligned to the ISA-S88/S95 standard following Project phases: Requirements definition, detailed design generation, software configuration, system integration and Qualification testing.
- Perform technical analysis activities, such as requirements gathering and performing gap analysis of user requirements against software functionality as well as defining PCS and MES solution architectures and developing detailed design specifications
- Define functional requirements through client interviews, documentation analysis and Work Flow Process Mapping along with the development of Electronic Procedures
- Provide PCS and MES trouble shooting services, issue resolution, root cause analysis, CAPA implementation, and pro-active preventative procedures.
- Provide expert knowledge and experience to estimate the technical effort and cost required to implement complex PCS and MES solutions as well as proactively reporting on project progress against schedules
- Actively participate on technical and business project teams, ensuring that effective relationships are built and maintained being responsible for technical deliverables during the entire lifecycle of PCS and MES solution development projects
- This position is responsible for ensuring cGMP/Regulatory compliance with internal/external policies, guidelines; these include internal SOP’s, departmental standards and conventions.
- This position interacts with external organizations, consultants and vendors as required in the successful accomplishment of project assignments.
Minimum a Bachelor's in Engineering, Computer Sciences or similar.
- 5+ years experience in automation in the pharmaceutical industry, including experience in manufacturing, engineering, or information systems
- Specific experience in process automation, MES and batch manufacturing industry stands (ISA S88 & S95)
- Experience with automated batch processing systems such as Rockwell, DeltaV, Siemens PCS7
- Experience with MES systems such as OpCenter, Werum PAS-X, Syncade, Invensys, POMSnet, Camstar, Elan
- Hands on experience in Recipe and Workflow Authoring and on experience in configuring master data and equipment in MES.
- Experience in cGMP and manufacturing operations in FDA regulated facility.
- Proficiency in automation solutions such as Siemens PCS7, Siemens OpCenter, Werum PAS-X, Batch, PLC systems, HMI packages, SCADA systems, Visual Basic and PC networking technology.
- Proficient programmer in one or more automation programming languages
- Proficient developer of MES electronic master batch records
- Demonstrated competence with electrical power and distribution systems, NEC codes, electrical installations and electrical panel building.
- Integration of PCS and MES systems with shop floor systems and instrumentation
- Knowledge of S88/S95 principals
- Knowledge of CSV, CMC, and regulatory submission requirements.
- Knowledge of SQL and general database concepts.
- Proficient in project management principles and project lifecycle phases.