Mes System Engineer

Eli Lilly Eli Lilly · Pharma · Alzey, Germany

This role is for an MES System Engineer in the pharmaceutical industry, focusing on designing, developing, implementing, and maintaining Manufacturing Execution Systems (MES) to optimize production processes, ensure data accuracy, and maintain compliance with GMP regulations. The role involves integrating production operations with business systems and collaborating with cross-functional teams.

What you'd actually do

  1. You will bring your technical knowledge and experience to design, develop, implement, enhance, and maintain our MES solution that integrate production processes with business systems to optimize manufacturing efficiency, quality, and safety.
  2. Must conduct testing, troubleshooting, and ongoing maintenance of MES to ensure system reliability and accuracy of data.
  3. Must ensure documented processes and procedures are in place for all activities to meet quality and compliance standards.
  4. Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly policy and procedures, and local procedures to maintain product quality and safety.

Skills

Required

  • Bachelor’s degree in software engineering, Computer Science, Computer Engineering, or a related field.
  • Minimum of 2+ years’ experience with an MES system (Rockwell Pharma suite preferred), preferably in the pharmaceutical or life sciences industry.
  • Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
  • Strong analytical and problem-solving skills to identify and resolve technical issues related to MES systems, configurations, or integrations.
  • Adaptability and flexibility to work in a fast-paced and dynamic environment (Agile business value delivery mindset).

Nice to have

  • Master’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
  • Experience working with MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X.
  • Expertise with programming languages such as C++, Java, Python, and SQL.
  • Expertise with related technologies and standards, including ISA-95, OPC, and data historians.
  • Expertise in integrating MES systems with other enterprise systems, such as ERP (Enterprise Resource Planning), EWM (SAP Extended Warehouse Management System), SCADA (Supervisory Control and Data Acquisition), and others, to ensure seamless data flow and system interoperability.
  • Understanding of cybersecurity concepts and best practices related to MES technologies.
  • Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
  • Demonstrated ability to thrive in an agile and innovative environment, with experience using agile management tools such as Jira to streamline project workflows and enhance team collaboration and build solutions business value delivery driven through the entire lifecycle (designing, implementing, automating, modernizing, maintaining, and optimizing solutions).
  • Experience with Computer System Validations.
  • Experience with technical mentoring and developing technical team members.
  • Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
  • Proficient in using ServiceNow for effective incidents and change management, ensuring seamless operations and minimal disruptions.
  • Preferred experience in the pharmaceutical industry, leveraging skills to contribute to advancements in healthcare.
  • Experienced in using testing tools such as HP-ALM and Jira to ensure the quality and reliability of software products.

What the JD emphasized

  • Must have a strong understanding of Manufacturing processes and practices.
  • Must have a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement in manufacturing operations.
  • Must conduct testing, troubleshooting, and ongoing maintenance of MES to ensure system reliability and accuracy of data.
  • Must stay up to date with emerging trends in MES technologies.
  • Must ensure documented processes and procedures are in place for all activities to meet quality and compliance standards.
  • Experience with GMP regulations.
  • Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly policy and procedures, and local procedures to maintain product quality and safety.
  • Must have Strong Analytical and Problem-solving skills.
  • Must have Excellent communication skills.
  • Must effectively influence the business to drive value and to implement the appropriate digital solutions.