Senior GxP Validation & QA Analyst

Dexcom Inc.; Penang; On-site; MYR 120,000 - 210,000; Full time

Job summary

Dexcom Inc. in Penang, Malaysia seeks an expert in validation of GxP-regulated systems to lead CSV/CSA programs within our IT/OT environment.

You will validate MES/ERP/QMS and ensure FDA 21 CFR Part 11 compliance across global systems while coordinating with manufacturing and quality teams. The role requires at least 5 years of experience in regulated validation, strong communication, and project leadership skills.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or related discipline.
• Minimum of 5 years validating manufacturing systems and regulated computer systems in medical/regulated industries.
• Experience validating MES/ERP/QMS/EDMS and manufacturing automation solutions including PLC/SCADA/Data Historians/EBR.
• Strong knowledge of FDA 21 CFR Part 11, ISO 13485, EU MDR and related requirements.

Responsibilities

• Serve as SME for validation and compliance of GxP-regulated platforms.
• Lead verification and validation activities (CSV, CSA, IQ/OQ/PQ/PPQ).
• Provide QA/QC guidance for IT and OT systems with regulatory focus.
• Perform GxP risk assessments at system, function, and data levels.
• Develop and maintain validation deliverables across the SDLC.
• Communicate progress and risks to cross-functional teams and leadership.
• Independently lead validation initiatives across projects of varying complexity.

Skills

GxP knowledge

CSV/CSA expertise

Risk-based validation

Cross-functional leadership

Attention to detail

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Excel

MiniTab

Database applications

Job description

Dexcom Inc. in Penang, Malaysia seeks an expert in validation of GxP-regulated systems to lead CSV/CSA programs within our IT/OT environment.

You will validate MES/ERP/QMS and ensure FDA 21 CFR Part 11 compliance across global systems while coordinating with manufacturing and quality teams. The role requires at least 5 years of experience in regulated validation, strong communication, and project leadership skills.