SW Design Transfer and IT Support

SW Design Transfer and IT-Support

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

This is an outstanding opportunity to be at the forefront of detailed software design transfer and IT support within a best-in-class organization!

Key Responsibilities:

• Be responsible for the process from R&D to manufacturing and service, ensuring compliance with IEC 62304, ISO 13485, and FDA software design control requirements.
• Collaborate with R&D, Manufacturing, and Quality teams to ensure software specifications meet manufacturability, scalability, deployment, and maintenance requirements.
• Define and optimize software deployment processes in a manufacturing, maintenance, and service environment, including installation, configuration, validation, and version control.
• Develop and maintain Standard Operating Procedures (SOPs) and training programs.
• Select, develop, and qualify computerized equipment, software tools, and environments used in manufacturing.
• Qualify and validate computerized equipment to meet cGMP, GAMP 5, and 21 CFR-Part 11 standards.
• Provide basic IT infrastructure support for manufacturing and laboratory operations, ensuring alignment with corporate IT policies and cybersecurity standards.
• Ensure software and computerized systems align with regulatory standards, including ISO 9001, ISO 13485, IEC 62304, FDA CFR Part 820, and EU MDR.
• Perform equipment risk assessments (FMEA, gap analysis) and fix equipment issues related to software.
• Support sophisticated technical investigations.
• Provide technical support to Manufacturing, Supply Chain, and Service teams for software-related manufacturing challenges beyond routine operations.

Key Requirements:

• Degree in Software Engineering, Computer Science, Electrical or Mechanical Engineering, or a related field, or equivalent experience.
• Demonstrated ability in software validation, design transfer, and computerized equipment qualification within a regulated industry (medical devices, pharmaceuticals, biotech, or manufacturing).
• Solid understanding of IEC 62304, ISO 13485, cGMP, GLP, CAPA, Track Wise, and risk analysis tools.
• Proficiency in device-based software products deployment, maintenance, and validation methodologies (IQ/OQ/PQ).
• Excellent communication skills.
• Strong analytical and problem-solving skills coupled with the ability to work independently and collaboratively in a fast-paced, team-oriented environment.

Join Lonza AG and be part of a team that is determined to efficiently implement brand-new solutions and drive continuous improvement in a collaborative environment. Your expertise will help us deliver best-in-class products and services that positively impact millions of lives every day!