Qualification & Compliance Engineer

About the role

Novartis is hiring a Qualification & Compliance Engineer in Amiria, Egypt, on a hybrid basis. The role ensures quality and safety standards are embedded across engineering operations, driving compliance within the Engineering department. It covers commissioning, qualification and calibration activities in both capital projects and routine manufacturing, supporting audits and regulatory expectations.

Key responsibilities

• Coordinate calibration, re-qualification and validation activities across equipment, facilities, utilities and systems, including external service providers.
• Work with vendors and cross-functional teams (Engineering, Quality, Safety, Operations) to run compliance activities.
• Lead planning and coordination meetings for calibration, HVAC re-qualification, re-validation, cleanroom and thermal validation.
• Oversee qualification, commissioning, calibration, HVAC validation, cleanroom validation and maintenance using a risk-based approach.
• Ensure timely closure of quality, HSE observations, deviations, corrective actions and compliance tasks.
• Investigate engineering deviations and equipment failures through root cause analysis and corrective actions.
• Track, analyse and report compliance KPIs, and support audits with accurate documentation and evidence.
• Promote continuous improvement, safety and data integrity cultures through walkthroughs, training support and process improvements.

Required profile

• Degree in Engineering (Bachelor's or Master's), preferably Electrical or Mechanical.
• At least two years of experience in qualification, calibration or instrumentation within the pharmaceutical industry.
• Fluent English communication skills.

Required skills

• Calibration and qualification methodologies for engineering systems and equipment.
• Root cause analysis and quality frameworks, including document control.
• Good Manufacturing Practice and health, safety and environmental standards.
• Desired: GMP, change controls, business continuity, cost management, data analytics, TPM and operational excellence.