C&Q Engineer II (m/f/d) Mengeš

Updated: March 08, 2024 09:30 AM GMT

Full-time Job in Domzale

Novartis Pharmaceuticals

Mengeš, Slovenia

About the role
Location: Mengeš #LI-Hybrid

We are looking for a new C&Q Engineer II (m/f/d) for our Maintenance team. You will be responsible for support in planning, executing and reporting on commissioning & qualification for CAPEX projects and/or routine manufacturing operation ensuring GxP compliance of plant/facilities/equipment.

Key Responsibilities:
• Perform new equipment FAT / SAT / inspections in project.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Investigate deviations (root cause analysis).
• Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets).
• Perform GMP risk assessments (incl. Sensors SRA).
• Create DQ, IQ and OQ protocols.
• Execute DQ, IQ and OQ.
• Create DQ, IQ and OQ reports.
• Develop periodic requalification plan.
• Execute periodic requalification plan.

Commitment to Diversity & Inclusion:
We are committed... More Detail