Commissioning and Qualification Engineer

Key Responsibilities

• Lead commissioning and qualification activities for capital projects, ensuring compliant and timely execution.
• Maintain facilities, equipment, and systems in a validated state through re-qualification and periodic reviews.
• Ensure all commissioning and qualification activities comply with quality standards, site procedures, and regulatory requirements.
• Develop, review, and maintain commissioning and qualification documentation, plans, protocols, and reports.
• Perform gap assessments and implement actions following updates to procedures, standards, and quality requirements.
• Drive project reviews, audits, and readiness assessments to support successful qualification and compliance outcomes.
• Manage deviations, deficiencies, and investigations, including root cause analysis and corrective actions.
• Partner with Quality Assurance, Manufacturing, Manufacturing Science and Technology, Engineering, and project teams to achieve qualification objectives.
• Provide engineering compliance oversight, conduct self-inspections, and support quality review activities.
• Monitor qualification deliverables, training completion, and system maintenance activities to ensure ongoing compliance.

Essential Requirements

• Degree in Engineering or an equivalent technical discipline.
• Fluent English communication skills with proficiency in the local language.
• More than 5 years of pharmaceutical engineering, commissioning, qualification, or compliance experience.
• Proven technical expertise delivering safe, effective, and fully compliant engineering projects.
• Deep understanding of Good Manufacturing Practice requirements and regulatory compliance standards.
• Advanced knowledge of Health, Safety, and Environment principles within a regulated manufacturing environment.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.