Senior Manufacturing Systems Expert

Location: Kundl

Salary Range

€66,918.00 - €112,600.00

Job Description Summary

• Location: Kundl, Austria #LI-HYBRID
• Internal job title: Senior Manufacturing Systems Expert
• This role is based in Kundl. Novartis is unable to provide relocation support, please apply only if this location and relocation requirement are feasible for you.

About the role

The Manufacturing Systems Expert MES provides technical expertise and ownership for the implementation of Manufacturing Execution System (MES) and electronic Batch Records (eBR) for one manufacturing line.

The role supports the full MES implementation lifecycle from requirements definition and design through configuration/development, testing, qualification and deployment. A key focus is ensuring harmonization with existing MES implementations, compliant integration with manufacturing and enterprise systems – vertical integration and establishing sustainable internal MES capabilities to ensure operational readiness and reliable ongoing operation.

Key Responsibilities

• Lead and support MES/eBR implementation across requirements, design, configuration/development, testing, qualification and rollout.
• Translate manufacturing process and user requirements into robust MES/eBR functional and technical solutions.
• Design, configure and maintain electronic batch records (eBRs) in accordance with manufacturing, quality, regulatory and business requirements.
• Ensure harmonization and reuse of existing MES standards, templates and solutions, while addressing RPP5-specific manufacturing requirements.
• Define, coordinate and support interfaces between MES and connected manufacturing/enterprise systems, such as SAP, automation/process control systems and other relevant production systems.
• Plan, execute and document testing, verification and CSV/qualification activities in collaboration with Manufacturing, Quality, Engineering, Automation and IT.
• Provide MES expertise during commissioning, qualification, production start-up and operational readiness of the RPP5 manufacturing line.
• Troubleshoot complex MES/eBR issues and coordinate resolution across internal teams, IT and external suppliers.
• Ensure compliant lifecycle management of computerized manufacturing systems, including changes, periodic reviews, maintenance and system updates.
• Establish sustainable internal MES knowledge and ownership, including technical documentation, knowledge transfer and support processes for transition into routine operations.

Essential Requirements

• Bachelor's or Master's degree in IT, Engineering, Automation, Manufacturing Technology or a comparable technical discipline, or equivalent technical education combined with relevant professional experience.
• Minimum 3-5 years of relevant professional experience in manufacturing systems, IT/OT, automation, engineering or a comparable technical environment.
• Practical experience with Manufacturing Execution Systems (MES) and/or electronic Batch Record (eBR) solutions in a manufacturing environment.
• Experience in project management and coordination of technical or digital manufacturing projects, ideally covering implementation from requirements and design through testing, qualification and deployment.
• Demonstrated ability to coordinate cross-functional teams, workstreams and external suppliers, ensuring alignment of activities, dependencies, priorities and deliverables.
• Experience working within a GxP-regulated manufacturing environment, including good knowledge of Computerized System Validation (CSV) and qualification principles.
• Technical understanding of system integration and interfaces between MES and systems such as SAP, automation and process control systems (PCS).
• Ability to translate complex manufacturing processes and business needs into structured requirements, technical solutions and executable implementation activities.
• Strong stakeholder management, communication and organizational skills, with the ability to work effectively across Manufacturing, Quality, Engineering, Automation, IT and external partners.
• Fluency German and good English skills, combined with a proactive, structured, accountable and solution-oriented working style.

Desirable Requirements

• Experience with PAS-X or a comparable pharmaceutical MES/eBR platform.
• Experience in MES deployment for new manufacturing lines, facility expansions or major manufacturing projects.
• Experience with SAP integration and/or automation/process control systems (PLC/PCS) in a manufacturing environment.
• Knowledge of GMP requirements and regulatory expectations for computerized manufacturing systems.
• Experience with commissioning, qualification, start-up and transition from project into operational support.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

What you will receive

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65,605.54 EUR/year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.