合同工 Manufacturing Process Engineer 工作, 薪水 up to MYR 5,000, Manpower Staffing Services (Malaysia) Sdn. Bhd. Pulau Pinang 公司招聘中 - Ricebowl

Job Requirement:

• Bachelor’s degree in engineering. Preferable in Biomedical, Mechanical,or Chemical

• 2-5 years of working experience in related field.

• Working knowledge of validation lifecycle activities, including IPM,TMV, IQ/OQ/PQ, and Process Characterization (PC)

• Experience authoring and executing validation protocols and preparing validation reports

• Understanding of the relationship between design requirements, risk management), design controls, and validation documentation

• Excellent written and verbal communication skills, including the ability to provide timely project status updates and communicate effectively with cross-functional teams.

Job Description:

• Support global remediation initiatives by executing manufacturing validation remediation activities.

• Review, update, and remediate validation documentation, including In ProcessMonitoring (IPM), Test Method Validation (TMV), OperationalQualification/Performance Qualification (OQ/PQ), and Process Characterization(PC)

• Develop, author, and execute validation protocols in accordance with quality system and regulatory requirements

• Analyze validation data and prepare comprehensive validation reports to document results and conclusions.

• Ensure validation activities are aligned with design requirements, risk management documentation, and applicable regulatory standards

• Assess existing validation documentation to identify gaps and implement compliant remediation solutions

• Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Operations, to support remediation deliverables

• Ensure all remediation deliverables are completed within project timelines while maintaining compliance with FDA, ISO 13485, and internal quality system requirements.

• Identify technical issues, perform root cause analysis, and recommend appropriate corrective actions to support successful project execution

• Contribute to continuous improvement initiatives that enhance validation processes, documentation quality, and overall operational efficiency

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