Pharma Process Excellence Specialist – Data & Compliance

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

Zusammenfassung

Novartis is seeking a Process Expert to transform manufacturing through data, digital innovation and process excellence. You will support Austrian sites remotely while collaborating with cross-functional teams to ensure product quality and process robustness.

Responsibilities include data analysis, KPI development, and maintaining compliant GMP documentation. The role emphasizes CAPA management and change controls within a global pharmaceutical context.

Qualifikationen

• Bachelor's degree or higher in a scientific discipline (Pharmacy, Biotechnology, Chemical Engineering, Life Sciences or related).
• Fluent English required.
• Experience in GMP-regulated pharmaceutical/biotech manufacturing.
• Strong GMP, data integrity, process validation and quality systems knowledge.
• Experience managing deviations, change controls, and CAPAs.
• Proficient in process data analysis, statistics, trend analysis and RCA.
• Experience with MES/SAP/eQMS and digital manufacturing environments.

Aufgaben

• Analyze process data, identify trends, and deliver insights to improve manufacturing performance and product quality.
• Develop and maintain KPIs, dashboards, and control charts for process monitoring.
• Create and maintain compliant manufacturing documentation (Master Batch Records, SOPs).
• Support deviation investigations and CAPA implementation.
• Coordinate change controls and ensure regulatory/quality compliance.
• Prepare and support validation/revalidation and CPP documentation.
• Drive continuous improvement for robustness, compliance, and efficiency.
• Provide process expertise and cross-functional training with Manufacturing, Quality, MS&T and Digital teams.

Kenntnisse

Process data analysis

Statistical evaluation

Root cause investigation

English fluency

GMP/compliance knowledge

Deviation/change control experience

Ausbildung

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

Tools

Manufacturing Execution Systems (MES)

SAP

Electronic quality systems

Digital manufacturing environments

Jobbeschreibung

Novartis is seeking a Process Expert to transform manufacturing through data, digital innovation and process excellence. You will support Austrian sites remotely while collaborating with cross-functional teams to ensure product quality and process robustness.

Responsibilities include data analysis, KPI development, and maintaining compliant GMP documentation. The role emphasizes CAPA management and change controls within a global pharmaceutical context.