Quality Validation Specialist - eDHR & CSV Expert

Becton, Dickinson and Company; Kulim; On-site; MYR 134,000 - 190,000; Full time

Job summary

Becton Dickinson is seeking a Validation & Compliance professional in Malaysia to develop and execute validation plans for eDHR systems, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and ISO 13485. You will coordinate with IT, OT, manufacturing, and QA teams to maintain validated states during system updates.

The role emphasizes data integrity, accurate real-time data capture, and thorough documentation for regulatory submissions.

Qualifications

• Bachelor's degree or equivalent in a relevant field plus hands-on validation experience.
• Experience developing and executing validation protocols for software systems and equipment.
• Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
• Knowledge of data integrity, traceability, and regulatory alignment in manufacturing environments.

Responsibilities

• 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.
• Collaborate with Quality Assurance to align validation with broader quality goals.
• Validate that production data is captured and stored accurately in real-time with traceability.
• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Participate in audits and provide documentation to support compliance.

Skills

eDHR systems

MES platforms (Apriso)

validation protocols (IQ/OQ/PQ)

CSV validation principles

data integrity

regulatory compliance

data analysis & reporting

cross-functional collaboration

Education

Bachelor's degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology

Tools

Apriso

Job description

Becton Dickinson is seeking a Validation & Compliance professional in Malaysia to develop and execute validation plans for eDHR systems, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and ISO 13485. You will coordinate with IT, OT, manufacturing, and QA teams to maintain validated states during system updates.

The role emphasizes data integrity, accurate real-time data capture, and thorough documentation for regulatory submissions.