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Novartis

Global pharmaceutical company delivering science-based innovations

Senior Manufacturing Systems Expert

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeKundl, Austria

About the Job

Requirements

  • A 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.
  • A minimum of 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.
  • Fluency in German and good English skills.
  • A proactive, structured, accountable, and solution-oriented working style.

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.

Desired Qualifications

  • Experience with PAS-X or a comparable pharmaceutical MES/eBR platform.
  • Experience with 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.
  • Data analytics.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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