Kerja Sepenuh Masa, Commissioning and Qualification Engineer di Novartis Farmacéutica Selangor - Maukerja

• 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.
• Why Novartis:*
• Helping people with disease and their families takes more than innovative science.

It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? **************

• Benefits and Rewards:*
• Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)OperationsProduction / ManufacturingMalaysiaSelangorMY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (*************4)Technical OperationsFull timeRegularNoTechnical OperationsOperationsMalaysiaREQ-10083755