Digital Manufacturing Systems Expert

Novartis; Lavamünd; Hybrid; EUR 14.000 - 26.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Zusammenfassung

Novartis in Romania is seeking a Manufacturing Systems Expert to drive qualification, validation, and risk management across manufacturing systems in a GxP-regulated environment. You will collaborate across validation, process engineering, quality, IT, and manufacturing to optimize systems, maintain electronic batch records, and ensure data integrity while supporting continuous improvement.

The role offers a hybrid work arrangement and opportunities to influence digital manufacturing and

Qualifikationen

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related field.
• Fluency in English.
• Proven experience supporting pharmaceutical or biotechnology manufacturing processes in a GxP-regulated environment.
• Strong knowledge of qualification, validation, data integrity, risk management, and regulatory compliance requirements.
• Hands-on experience with Manufacturing Execution Systems, electronic batch records, recipes, and manufacturing master data.
• Strong collaboration and communication skills across manufacturing, quality, information technology, and engineering teams.

Aufgaben

• Lead qualification, validation, cleaning validation, and risk management activities across manufacturing systems.
• Support commissioning, testing, and qualification of equipment, utilities, and manufacturing systems.
• Analyze process and system data to troubleshoot issues and drive continuous improvement.
• Translate manufacturing process requirements into compliant system configurations and execution workflows.
• Maintain and optimize electronic batch records, recipes, master batch records, and bill of materials structures.
• Author and maintain GxP documentation while ensuring data integrity, traceability, and audit readiness.
• Support deviations, corrective and preventive actions, change controls, and lifecycle management activities.
• Deliver training, subject matter expertise, and knowledge transfer across manufacturing and operational teams.

Kenntnisse

English fluency

GxP compliance

MES

Data integrity

Cross-functional collaboration

Ausbildung

Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related field

Tools

MES (Manufacturing Execution Systems)

Electronic Batch Records

Master Data management

Jobbeschreibung

Novartis in Romania is seeking a Manufacturing Systems Expert to drive qualification, validation, and risk management across manufacturing systems in a GxP-regulated environment. You will collaborate across validation, process engineering, quality, IT, and manufacturing to optimize systems, maintain electronic batch records, and ensure data integrity while supporting continuous improvement.

The role offers a hybrid work arrangement and opportunities to influence digital manufacturing and