Validation Engineer

Validation and verification planning: Prepare validation and verification plans and reports, including but not limited to shelf-life verification, sterilization validation, and other validation activities required by applicable standards and regulations.
Validation execution: Coordinate and implement validation and verification activities according to approved protocols, ensuring timely completion and compliance with regulatory and quality requirements.
Validation documentation management: Establish, maintain, and update validation and verification master lists for the assigned area to ensure accurate tracking and effective document control.
Regulatory documentation support: Prepare and maintain validation and verification documents required for product registration, regulatory submissions, and audits.
Calibration management: Maintain calibration plans and equipment calibration lists, coordinate third-party calibration services, and ensure all measuring equipment remains within valid calibration status.
Deviation and CAPA support: Investigate validation deviations, document findings, and support corrective and preventive actions (CAPA) to ensure process compliance and continuous improvement.
Cross-functional collaboration: Work closely with Technical, Production, and Regulatory Affairs to support validation activities, product launches, and process changes.

Education: Bachelor’s degree in Engineering Science, Biomedical, or a related field
Experience: 1–2 years in a manufacturing Quality Assurance role, preferably in the manufacturing, medical device, or pharmaceutical industry.
Process expertise: Solid understanding of Quality Management Systems, Validation Processes, and Statistical Quality Control Techniques.
Problem-solving and analytics: Proficient with quality control tools and software, such as SPC, FMEA, and Six Sigma
Language proficiency: Good command of English and Bahasa Malaysia
Fresh graduates are encouraged to apply!

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