Qualification & Compliance Engineer

About the role

You will play a key role in embedding quality and safety standards across engineering operations at Novartis. The position focuses on driving compliance, supporting robust engineering procedures, and ensuring adherence to Good Manufacturing Practice, health, safety, and environmental standards.

Key responsibilities

• Coordinate calibration, re‑qualification and validation activities for equipment, facilities, utilities and systems, including external service providers.
• Collaborate with vendors and cross‑functional teams (Engineering, Quality, Safety, Operations) to execute compliance activities.
• Lead planning, execution and coordination meetings for calibration, HVAC re‑qualification, cleanroom and thermal validation.
• Oversee qualification, commissioning, calibration and validation tasks using a risk‑based approach.
• Ensure timely closure of quality, HSE observations, deviations, corrective actions and audit findings.
• Investigate engineering deviations and equipment failures through root‑cause analysis and implement corrective actions.
• Track, analyse and report compliance KPIs to meet planned timelines.
• Support audits by maintaining accurate documentation and providing required evidence.

Required profile

• Degree in Electrical or Mechanical Engineering (BSc or MSc).
• Minimum two years of experience in qualification, calibration or instrumentation within the pharmaceutical industry.
• Strong knowledge of calibration and qualification methodologies for engineering systems and equipment.
• Experience with pharmaceutical or chemical manufacturing equipment and processes.
• Solid understanding of root‑cause analysis techniques and quality frameworks, including document control.

Required skills

• Calibration
• Qualification
• Validation
• HVAC validation
• Cleanroom validation
• Root cause analysis
• GMP compliance
• Instrumentation