Commissioning and Qualification Engineer

Job ID

REQ-10083755

Jul 24, 2026

Malaysia

Available in: English

Summary

#LI-HybridLocation: Selangor, MalaysiaRelocation Support: This role is based in Selangor, Malaysia. Novartis is unable to offer relocation support: please only apply if accessible.As a Commissioning and Qualification Engineer, you will play a pivotal role in ensuring equipment, facilities and systems are commissioned, qualified and maintained in a validated state throughout their lifecycle. From supporting major capital investment projects to driving requalification and periodic review activities, your work will directly contribute to product quality, patient safety, and operational excellence. Working in close partnership with Engineering, Quality, Manufacturing, and project teams, you will help ensure all commissioning and qualification activities are executed in compliance with Good Manufacturing Practice standards and site procedures, enabling the reliable delivery of medicines to patients worldwide.

About the Role

Key ResponsibilitiesLead 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 RequirementsDegree 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? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

Division

Operations

Business Unit

Production / Manufacturing

Location

Malaysia

Site

Selangor

Company / Legal Entity

MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054)

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

Technical Operations Operations Malaysia

Job ID

REQ-10083755

Commissioning and Qualification Engineer

Apply to Job

Job ID

REQ-10083755

Commissioning and Qualification Engineer

Apply to Job