Production Systems Expert

The role is responsible for coordinating and continuously improving manufacturing systems in compliance with GMP requirements. Represent the assigned manufacturing area in MES and other Manufacturing Systems initiatives, ensuring that electronic batch records and related digital capabilities are implemented in line with business, operational, and compliance requirements. Collaborate with business stakeholders and cross-functional teams to identify needs, define requirements, and deliver effective and value-added digital solutions.

Design, create, maintain, and continuously improve MBRs in line with operational, quality, and compliance requirements.

Major Accountabilities:

• Coordinate end-to-end MES implementation activities for all products, including current and future MES releases, upgrades, and related digital initiatives.
• Identify improvement opportunities by analyzing system performance, operational needs, and industry best practices.
• Ensure inspection readiness by maintaining up-to-date manufacturing systems procedures, documentation, and compliance records, and by supporting internal and external audits/inspections.
• Act as a subject matter expert for assigned manufacturing systems, providing technical and functional guidance while promoting knowledge sharing and cross-training within the Manufacturing Systems team.
• Provide expertise for manufacturing and packaging processes during the design, testing, implementation, and continuous improvement of manufacturing system solutions and MBRs.
• Coordinate, maintain, and continuously improve manufacturing systems, including MES, SAP, MACO, Seidenader Track & Trace, AGE, Historian, and GISC, ensuring their reliable and compliant operation.
• Collaborate with stakeholders and cross-functional teams to identify current and future business needs, drive process simplification, system optimization, automation and digitalization opportunities, and contribute to new projects, enhancements, and digital initiatives.
• Support site digital transformation initiatives and contribute to the successful execution of the site's digital roadmap.
• Contribute to end-to-end project implementation activities, including requirements gathering, solution design, testing, deployment, user training, go-live, and hypercare support.
• Provide day-to-day operational support and troubleshooting for manufacturing systems, ensuring timely resolution of system-related issues and minimizing impact on production operations.
• Investigate recurring or critical system issues, support root cause analysis, and drive sustainable corrective and preventive actions in collaboration with relevant functions.

Minimum Requirements:

• Bachelor’s or master’s degree in engineering, Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related field.
• Minimum 3 years of experience in production operations, manufacturing systems, or related functions in a GMP/GxP-regulated environment. Experience with MES is considered an advantage.
• Fluent in written and spoken English.
• Knowledge of manufacturing processes and process-oriented ways of working.
• Strong interpersonal, collaboration, and communication skills with the ability to work effectively across Manufacturing, Quality, Engineering, IT/OT and other functions.
• Strong analytical thinking and problem-solving skills, with the ability to investigate issues and implement effective corrective actions.
• Understand end-to-end manufacturing processes and system interfaces and effectively assess the potential operational and compliance impact of system changes or incidents.
• Team-oriented and customer-focused mindset.
• Ability to manage multiple priorities and support project execution.
• Business acumen with the ability to understand operational needs and translate them into effective solutions.
• Continuous improvement and operational excellence mindset.
• Strong digital mindset with the ability and willingness to quickly learn new manufacturing technologies, systems, and digital solutions.

Skills Desired

Data Analytics