Validation Engineer

Job Description Summary

Conduct Validations on all e-DHR related activities

Job Description

P3-14201

• Validation Planning & Execution
• Develop and execute validation protocols (IQ / OQ / PQ) for eDHR systems and related equipment.
• Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
• Conduct performance testing and document results to confirm system functionality and reliability.
• System Compliance & Quality Assurance
• Ensure eDHR systems comply with internal quality standards and external regulations.
• Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
• Participate in audits and provide documentation to support compliance.
• Process & Data Integrity
• Validate that eDHR systems accurately capture and store production data in real-time.
• Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
• Ensure traceability and error-proofing mechanisms are functioning as intended.
• Documentation & Reporting
• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Record and analyze test data to identify anomalies and ensure systems meet specifications.
• Prepare detailed reports for internal review and regulatory submissions.
• Cross-Functional Collaboration
• Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
• Support changing control processes and ensure validated state is maintained during updates.
• Train and mentor team members on validation procedures and compliance requirements

Qualifications

Required Skills

Optional Skills

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)

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