eDHR Validation Engineer (IQ/OQ/PQ) - Regulatory Compliance

BD Nogales Norte; Kulim; On-site; MYR 40,000 - 55,000; Full time

Job summary

A leading company in technology is seeking a qualified individual for the role focusing on validation and compliance within eDHR systems. The ideal candidate will have a degree in engineering or a related field, along with hands-on experience in digital manufacturing environments. Responsibilities include developing validation protocols, ensuring compliance with quality standards, and documenting validation efforts. This role is based in Kedah, Malaysia and offers a full-time schedule.

Qualifications

• Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
• Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
• Experience preparing regulatory submission documents and internal review reports.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems.
• Ensure validation activities meet regulatory standards.
• Author and maintain validation documentation, including protocols and SOPs.

Skills

Hands-on experience with eDHR systems

Strong understanding of computer system validation (CSV)

Skilled in performance testing

Collaboration skills with IT, OT, Manufacturing, and Quality teams

Education

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

Tools

MES platforms (preferably Apriso)

Job description

A leading company in technology is seeking a qualified individual for the role focusing on validation and compliance within eDHR systems. The ideal candidate will have a degree in engineering or a related field, along with hands-on experience in digital manufacturing environments. Responsibilities include developing validation protocols, ensuring compliance with quality standards, and documenting validation efforts. This role is based in Kedah, Malaysia and offers a full-time schedule.