Job Description Summary

Conduct Validations on all e-DHR related activities

Job Description

P3-14201

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.

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.

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.

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.

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:

Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
Experience preparing regulatory submission documents and internal review reports.
Cross-Functional Collaboration
Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.
Experience supporting change control processes and maintaining validated states during system updates

Required Skills

Optional Skills

MYS Kedah - Bard Kulim (Malaysia)

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