Senior Validation Lead - GxP & CSV for Manufacturing Systems

Dexcom; Batu Kawan; On-site; MYR 180,000 - 280,000; Full time

Benefits offered by this job

Medical coverage

Cash allowances

Employee subsidies

Retirement savings

Wellness reimbursements

Leave benefits

EAP

Job summary

Dexcom Malaysia in Penang seeks a seasoned validation specialist to ensure regulatory compliance of IT and OT systems within GxP environments. You will validate MES, ERP, QMS, and EBR-related platforms, lead CSV/CSA efforts, and drive risk-based validation across the SDLC.

The role requires strong documentation, cross-functional collaboration, and communication with senior leadership to maintain inspection readiness and system integrity across global regions.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems in regulated industries.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, Clinical Data Management Systems, LIMS, and manufacturing automation.
• Strong understanding of FDA electronic records and signatures, GxP processes, and CSV expectations.
• CSA expertise and risk-based validation methodologies.
• Knowledge of FDA 21 CFR Part 11, 21 CFR 820, ISO 13485, and EU MDR requirements.
• Experience delivering full lifecycle CSV programs across IT and OT environments.
• Ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Lead verification and validation activities, including CSV, CSA, IQ/OQ/PQ/PPQ, and Master Validation planning.
• Provide QA/QC guidance for IT and OT systems and ensure regulatory compliance.
• Perform GxP risk assessments at system, functionality, and data-element levels.
• Advise IT/OT, Quality, Manufacturing on validation strategies and risk mitigation.
• Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, and EU MDR.
• Develop and maintain Validation Plans, Protocols, Risk Assessments, and Test Scripts.
• Communicate progress, risks, and issues to Dexcom teams and leadership.
• Lead validation initiatives across cross-functional projects of varying complexity.
• Design and improve quality policies, procedures, and systems supporting validation and CAPA.
• Apply Six Sigma and TQM to improve product safety, quality, and efficiency.
• Interpret specs and use MS Office, Excel, MiniTab, and databases to support quality objectives.

Skills

CSV principles

FDA CSA

GxP knowledge

Regulatory compliance

Risk assessments

Validation plans

Traceability matrices

Cross-functional collaboration

Education

Engineering

Quality

Computer Science

Life Sciences

Tools

MES

ERP

QMS

SCADA

PLC

Data Historians

EBR

Job description

Dexcom Malaysia in Penang seeks a seasoned validation specialist to ensure regulatory compliance of IT and OT systems within GxP environments. You will validate MES, ERP, QMS, and EBR-related platforms, lead CSV/CSA efforts, and drive risk-based validation across the SDLC.

The role requires strong documentation, cross-functional collaboration, and communication with senior leadership to maintain inspection readiness and system integrity across global regions.