Validation Engineer

BD; Kulim; On-site; MYR 60,000 - 80,000; Full time

Job summary

Syarikat teknologi perubatan yang terkemuka di Kulim, Malaysia, sedang mencari individu berkelayakan untuk menjalankan pengesahan sistem e-DHR. Calon ideal mempunyai ijazah dalam kejuruteraan bioperubatan dan pengalaman dalam melaksanakan protokol validasi. Tugas termasuk merancang dan melaksanakan validasi, serta bekerja rapat dengan pelbagai pasukan untuk memastikan pematuhan terhadap piawaian. Tawaran ini terletak di Kulim dan menawarkan cabaran dalam persekitaran pembuatan peralatan perubatan.

Qualifications

• Mempunyai pengalaman praktikal dengan sistem eDHR dan persekitaran pengeluaran digital.
• Mempunyai pengalaman dalam membangunkan dan melaksanakan protokol validasi (IQ/OQ/PQ).
• Mahir dalam pengujian prestasi, analisis data, dan laporan.

Responsibilities

• Merancang dan melaksanakan pengesahan serta dokumentasian.
• Mengendalikan ujian prestasi dan mendokumentasikan hasil.
• Berkolaborasi dengan pasukan Kualiti untuk mencapai matlamat kualiti yang lebih luas.

Skills

Pengalaman sistem eDHR

Pemahaman prinsip validasi sistem komputer

Kemahiran analisis data

Kemahiran pengujian prestasi

Kemahiran dokumentasi dan laporan

Education

Ijazah Sarjana Muda dalam bidang kejuruteraan bioperubatan

Ijazah Sarjana Muda dalam Jaminan Kualiti

Ijazah Sarjana Muda dalam Kejuruteraan atau Teknologi Maklumat

Tools

Sistem eDHR

Platform MES (Apriso)

Job description

15 jam yang lalu Jadilah salah seorang dalam kalangan 25 pemohon pertama

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 change 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.
• Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.
• Experience supporting change control processes and maintaining validated states during system updates.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

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

Bidang tugas

Jaminan Kualiti

Industri

Pembuatan Peralatan Perubatan