Position Purpose
Primarily accountable for the implementation, life cycle, and ownership of the Parenterals PCS/MES and PLC process recipes related to the Fill/ Finish 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 (Automation Engineering) 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 is responsible for implementing modifications related to the process improvements, changes, support, and maintenance of the Parenterals Control 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 North (Building 16N) 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, and 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 Computer Science.
Experience:
- 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.
- Functional knowledge of cGMPs and manufacturing operations in an FDA regulated facility is preferred and is a major aspect of the associated position.
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.
- 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.
Competencies:
- Customer Orientation (Internal/External)
- Enterprise Results and Value Orientation
- Collaboration and Influencing
- Strategic/Innovative
- Change Management
- Interpersonal Savvy
The expected base salary range for this position at hiring is $80,000 - $105,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
