Automated Process Lead

vor 2 Wochen

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

Job Summary


We are seeking a highly skilled Automated Process Lead to oversee the implementation, maintenance, and ownership of PCS/MES and PLC process recipes related to the specific value stream.



Key Responsibilities

  • Adhere 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.



  • Serve as a technical project subject matter expert for Execution Systems related project deliverables during design, construction, commissioning, and validation phases of CAPEX projects & OPEX initiatives & changes.



  • Provide 24/7 and/or on-call Manufacturing support of the facilities with the goal of maximizing facility uptime.



  • Track, remediate, and improve incidents associated with the assigned Value Stream.



  • Align and coordinate 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.



  • Coordinate interfaces with the Data Historian, Data Acquisition Systems, Building Management Systems, Central Alarm Management System, Manufacturing Control Network, and Enterprise applications.



  • Align and review deliverables from the different execution system work packages as a Recipe Lead. Ensure the right technical prioritization on project activities.



  • Collaborate closely with respective Project Managers to ensure deliverables are ready in time for the different milestones throughout the project. Work 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.



  • Responsible for Value Stream Recipe Owner resource management including assigning resources to daily activities (operations) and supporting project activities based on the Site Projects & Operations Portfolio.



  • Specific employee-related activities include, talent acquisition, training, career development, providing coaching, performance management (IPM), and compensation. Additionally, as a result of the matrix environment, may support resources from other functional areas.



  • Install and configure to the ISA-S88/S95 standard following Project phases: Requirements definition, detailed design generation, software configuration, system integration, and Qualification testing.



  • Participate 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.



  • Develop validation test cases and perform testing Interface with customer groups on the project to ensure we are designing, executing, and delivering to 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.





Requirements

  • Bachelor of Science in an Engineering or other Science discipline/Computer Science, or Management Information Systems.



  • 7+ years or more working experience in Execution Systems/Automation design and support. Several years' practical leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems/Automation.



  • Fluent in German and English language.



  • Considerable knowledge in the lifecycle manufacturing process (preferably in the related value stream).



  • 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 hands-on experience in configuring master data and equipment in MES.



  • Direct experience designing, building, deployment, 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.



  • Demonstrated ability to influence at all organizational levels through clear, concise, and impactful verbal and written communication skills.



  • Ability to build, mentor, and grow a high-performing and cohesive team.



  • Experience in Process Excellence methodology is desirable, but not required.





What We Offer

  • Excellent income potential and extended benefits.



  • For more information, please check out our global benefits below.



  • Two additional leave days for your personal wellbeing.



  • CSL-subsidized company bike leasing.



  • Childcare "Kita Frosch König" for up to 14 children.



  • Find Diversity, Equality, and Inclusion at all sites and with every colleague. Come as you are.




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