全职 Medical Devices : Validation Engineer 工作, 薪水 up to MYR 6,000, PERSOL Workforce Solutions Malaysia Johor 公司招聘中 - Ricebowl

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related field

• 3–5 years of experience in Validation Engineering within a Medical Device, Pharmaceutical, Biotechnology, or other regulated manufacturing environment

• Hands-on experience in process validation, equipment qualification, and quality system compliance

• Strong knowledge of ISO 13485 Quality Management Systems (QMS)

• Excellent analytical, troubleshooting, and problem-solving skills

• Strong communication and documentation abilities

• Ability to work effectively with cross-functional teams in a fast-paced manufacturing environment

Preferred Qualifications

• Experience with IQ/OQ/PQ and PPQ activities

• Familiarity with risk management methodologies and validation lifecycle requirements

• Exposure to audit preparation, regulatory inspections, and CAPA processes

• Knowledge of medical device manufacturing and quality assurance principles

• Execute process validation and equipment qualification activities in compliance with ISO 13485 requirements

• Develop and support Validation Master Plans (VMP), validation protocols, qualification documents, and validation reports

• Conduct risk assessments to identify critical process parameters and establish process control strategies

• Perform process validation and Process Performance Qualification (PPQ) studies to ensure consistent manufacturing performance

• Collaborate with Manufacturing, Engineering, and Quality teams to improve process robustness, product quality, and operational efficiency

• Review, maintain, and approve validation documentation in accordance with regulatory and internal quality standards

• Support internal and external audits and ensure timely closure of validation-related findings and corrective actions

• Participate in continuous improvement initiatives to enhance validation practices and manufacturing performance

• Stay current with industry regulations, validation trends, and best practices

• EPF
• SOCSO
• Allowance Provided
• Annual Leave
• Medical and Hospitalisation Leave
• EIS