Senior Automation Engineer, Process Recipe Owner at CSL Behring summary:
The Senior Automation Engineer, Process Recipe Owner is responsible for the implementation and management of process recipes in pharmaceutical manufacturing. This role focuses on ensuring adherence to global execution systems within manufacturing operations, overseeing technical project deliverables, and coordinating system interfaces. The engineer also implements modifications for process improvements and provides on-call support for operational processes in a regulated environment.
Primarily accountable for the implementation, life-cycle management, and ownership of process recipes. These recipes and associated S-88 based library objects leverage a batch manager for execution and integration to MES functions. This single recipe design philosophy is referred to as Recipe Driven Execution (RDE).
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 automation recipes and configuration across the RDE implementations.
- Incident tracking, remediation and improvement associated with the Fractionation Value Stream.
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 Fractionation Systems.
Qualifications:
- Bachelor of Science in an Engineering or other Science discipline/ Computer Science, or Management Information Systems.
- At least one year of Pharmaceutical Controls experience
- On-call support of a Pharmaceutical Manufacturing facility’s 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 pharmaceutical/regulated 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.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
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.
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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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Keywords:
automation, pharmaceutical manufacturing, process recipes, Manufacturing Execution Systems, ISA S88, ISA S95, technical project management, process automation, Fractionation Systems, recipe authoring
