Pharma Process SME - GMP & Continuous Improvement

Biopharma Careers; Österreich; Hybrid; EUR 54.000 - 66.000; Vollzeit

Benefits dieser Stelle

Bonus program

Pension scheme

Childcare facilities

Learning opportunities

Zusammenfassung

Novartis in Schaftenau, Austria is seeking a Process Expert to ensure safe, efficient, GMP-compliant manufacture of high-quality drug substances. You will support manufacturing operations through equipment qualification, cleanroom management, deviation handling, and maintaining GMP documentation.

As SME, you will drive continuous improvement, support regulatory inspections, coordinate with cross-functional stakeholders, and lead improvement projects in production.

Qualifikationen

• Bachelor's degree or equivalent in a life sciences/engineering field.
• Strong team player with good communication in diverse teams.
• Proficiency in English; native German required.

Aufgaben

• Ensure manufacturing of high-quality products safely and efficiently in own area.
• Coordinate equipment qualification and cleanroom activities.
• Manage local admin for service providers (cleaning, gowning).
• Handle deviations, implement actions, and coordinate changes.
• Create and maintain lifecycle documents for compliance and inspections.
• Represent SME during Health Authority inspections.
• Collaborate with cross-functional stakeholders to resolve issues.
• Lead improvements in the production environment.

Kenntnisse

Team player

Communication

English proficiency

German native

Ausbildung

Bachelor's degree in Process Engineering, Biotechnology, Biology, Chemistry, Pharmacy

Tools

Automation affinity

GMP documentation

Jobbeschreibung

Novartis in Schaftenau, Austria is seeking a Process Expert to ensure safe, efficient, GMP-compliant manufacture of high-quality drug substances. You will support manufacturing operations through equipment qualification, cleanroom management, deviation handling, and maintaining GMP documentation.

As SME, you will drive continuous improvement, support regulatory inspections, coordinate with cross-functional stakeholders, and lead improvement projects in production.