Validation Engineer

Becton Dickinson; Kulim; On-site; MYR 50,000 - 70,000; Full time

Job summary

Becton Dickinson is looking for a professional in Kulim, Malaysia to manage the validation of eDHR systems. The role involves developing and executing protocols, collaborating with Quality Assurance teams, and ensuring compliance with regulations.

The ideal candidate holds a Bachelor’s degree in a relevant field and has hands-on experience with eDHR systems and validation protocols. This position offers an opportunity to impact quality goals and regulatory compliance directly.

Qualifications

• Bachelor’s degree in a relevant field.
• Hands-on experience with eDHR systems and MES platforms.
• Experience developing validation protocols.
• Strong understanding of computer system validation.

Responsibilities

• Plan and execute validation protocols for eDHR systems.
• Ensure activities meet regulatory standards.
• Conduct performance testing and document results.
• Collaborate with QA teams and participate in audits.
• Train and mentor team members on validation procedures.

Skills

eDHR system validation

MES platforms

performance testing

data analysis

collaborative skills

Education

Bachelor’s degree in biomedical engineering

Bachelor’s degree in quality assurance

Bachelor’s degree in engineering

Bachelor’s degree in information technology

Job description

Responsibilities

• Plan, 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 and participate in audits.
• Validate that eDHR systems accurately capture and store production data in real‑time, monitoring data integrity across the manufacturing lifecycle.
• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Record and analyze test data, identify anomalies, and prepare detailed reports for internal review and regulatory submissions.
• Work with IT, OT, manufacturing, and quality teams to coordinate validation activities and support change control processes to maintain validated state.
• 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.
• 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, and to support change control processes.

Location

Primary Work Location: MYS Kedah – Bard Kulim (Malaysia).

Equal Opportunity Statement

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.