System Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Summary

Participates in semi-complex material specification, schematic preparation and appropriate follow-up. Provides support in semi-complex design, development, testing and modifications of solutions. Provides support in preparing explanations and clarifies information to enable proper interpretation and evaluation of semi-complex specifications, performance characteristics or other technical data. Participates in communicating semi-complex technical and commercial issues. May participate in recommending semi-complex new designs, new processes, or design changes to meet requirements.

Responsibilities:

• Translate product specifications for batch manufacturing with scales from 1 to 5000 liters into process requirements; identify all process inputs/outputs; identify the customers for every output, and understand their needs; identify the suppliers for every input and impose specifications
• Understand cause & effect relationships between process parameters and product performance; identify critical to quality (CTQ) process parameters; identify potential process failure modes & implement risk mitigations
• Identify all process CTQ measurement points; define all process CTQ warning and control limits, define data collection plan, develop response plan for out of control situations
• Process Validation: Verify performance against Process requirements. Validate performance against product specifications

Required Skills:

• Experience working in regulated industry such as ISO 9000, cGMP
• Batch Process Engineering experience in a Manufacturing/Industrial environment
• Experience with formal methodologies for Problem Solving
• Flexibility to adapt to changing technologies, project requirements, and team needs.

Preferred Skills:

• Experience in Pharmaceutical or Biologics industry
• Automated Batch Process Engineering (PLC/DCS) experience in a Manufacturing environment
• Project Management experience
• Training in Safety and Environmental Regulations
• Process Validation experience including knowledge of FMEA/Risk Analysis
• Knowledge of Lean; Continuous Improvement Tools
• Liquid reagent manufacturing experience
• Experience with generation of Validation protocols and reports.
• Leadership of FMEA/Risk Analysis development

Education:

• Preferred: Degree in Chemical Engineering
• Relevant experience in Manufacturing is highly valued and may substitute for formal education.

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

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