Process Controls Engineer - cGMP -

Automation/Controls Engineer - cGMP Parenteral-

Primarily accountable for the implementation, life-cycle, and ownership of the Parenteral PCS/MES and PLC process recipes related to the Fill/ Finish production.  

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 ownership for all Execution Systems related project deliverables including oversight & review of contractors/integrators work during support projects
• Ownership of the process recipe and configuration across the Parenterals MES, PCS, and/or PLC systems for the Fill/ Finish Value Stream.
• Incident tracking, remediation and improvement associated with the Fill/ Finish Value Stream.
• Tests and evaluates production equipment and machinery to ensure reliability and efficiency.
• Adapts machine and equipment design to plant and production conditions. 

This scope will also include aligning and coordinating the definition of the required hardware with the System Owner; including the development of the software, and system coordination with the required project schedule to enable Commissioning and Validation of the Process Systems. Further, to coordinate and troubleshoot 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 Parenteral Systems.

Principal Accountabilities:

• Provides primary PCS support and works closely with the Plant Controls Support group to identify deficiencies, develop optimizations, and ensure proper equipment function.
• ·Aligns and reviews deliverables from the different execution system work packages as a Recipe Owner. Ensures the right technical prioritization on support activities. Works closely together with respective Department Manager to ensure deliverables are ready in time for the different milestones throughout operations. 
• Be the primary point of contact for the Parenterals South (Building 3/22) execution system for the Value Stream Process Owners and Manufacturing staff to ensure the overall recipe function 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, by working in collaboration with the value stream network.
• Writes & reviews Process system documentation as defined by the project. Participates in the creation & testing of software. Troubleshoots and corrects as needed.
• Knowledge of motion-based systems, utilizing shift registers, motion commands, tracking, and servo troubleshooting
• Electrical circuit troubleshooting and utilization of multi-meters/ signal generators 
• Electrical drawing interpretation, redlining, and corrections
• Participates in the creation of Parenterals PCS optimization and corrective change controls.
• Responsible for ES investigations and CAPAs.
• Collaborates with other disciplines across the site 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 of controls changes.
• Supports the coordination of Parenterals PCS Support and Optimization, with fellow automation engineers to balance workload across the group.
• Interfaces with customer groups of Fill/ Finish to ensure we are supporting, executing, and delivering in accordance with 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/ Computer Science, or Management Information Systems.
•  

Qualifications:

• 2+ Years of experience in supporting automation systems in a manufacturing environment.
• On-call support of a Pharmaceutical Manufacturing facility’s filling operations is strongly recommended.
• Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).
• Hands on experience in Recipe and Workflow Authoring.
• Direct experience in supporting automation and execution systems in a regulated large-scale Parenterals (filling) 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.

Special Training:

• Must have demonstrated capability for Rockwell Automation PLC Logic Development and troubleshooting. (RS Logix 500, 5000) Factory Talk View SE and ME development and troubleshooting experience is required. 
• ·Modicon PLC Logic programming and troubleshooting knowledge is strongly recommended.
• Oracle Database and Crystal Reports troubleshooting, querying, and programming knowledge is strongly recommended.
• ·Basic Networking troubleshooting and development practices in accordance with ISA 95 is required. 

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.

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.

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