Senior Manufacturing Systems Expert

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Kundl; Hybrid; EUR 67,000 - 113,000; Full time

Benefits offered by this job

Market-competitive base salary

Incentive program

Pension scheme

Childcare facilities

Learning and development opportunities

Worldwide career possibilities

Job summary

Novartis seeks a Senior Manufacturing Systems Expert in Kundl, Austria, to own MES/eBR implementation for a manufacturing line. You will lead lifecycle activities from requirements through deployment, ensuring integration with SAP and other enterprise systems.

Fluency in German and English, a technical degree, and 3–5 years in MES/eBR environments are required. This hybrid role offers a competitive package and career development within Novartis.

Qualifications

• Bachelor's or Master's degree in IT, Engineering, Automation, Manufacturing Technology or a comparable technical discipline.
• Minimum 3-5 years of relevant professional experience in manufacturing systems or similar environments.
• Hands-on experience with Manufacturing Execution Systems (MES) and/or electronic Batch Records (eBR) in manufacturing.
• Project management experience coordinating technical or digital manufacturing projects.
• Ability to coordinate cross-functional teams and external suppliers.
• Experience in a GxP-regulated environment with CSV/qualification knowledge.
• Technical understanding of system integration between MES and SAP/automation/PCS.
• Strong stakeholder management and communication skills.
• Fluency in German and good English.

Responsibilities

• Lead and support MES/eBR implementation across lifecycle stages (requirements, design, configuration, testing, qualification, rollout).
• Translate manufacturing requirements into robust MES/eBR solutions.
• Design, configure and maintain electronic batch records (eBRs) per regulatory requirements.
• Harmonize MES standards and reuse existing templates for RPP5.
• Define interfaces between MES and SAP/automation/PCS.
• Plan, execute and document testing and CSV/qualification activities with cross-functional teams.
• Provide MES expertise during commissioning and startup of the RPP5 line.
• Troubleshoot MES/eBR issues and coordinate resolution with internal teams and suppliers.
• Ensure lifecycle management of computerized manufacturing systems.
• Develop internal MES knowledge transfer and transition to routine operations.

Skills

German

English

Project management

Stakeholder management

GxP compliance

Regulatory knowledge

System integration

Translating requirements into tech

Education

Bachelor's or Master's degree in IT, Engineering, Automation, Manufacturing Technology

Tools

MES

eBR

SAP

Job description

Salary Range: €66,918.00 - €112,600.00

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.


• Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals.

Skills Desired Data Analytics

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.