Manufacturing Engineer

ManpowerGroup; Seberang Perai; On-site; MYR 67,000 - 112,000; Full time

Benefits offered by this job

Annual Leave

Medical and Hospitalisation Leave

SOCSO

EPF

EIS

Job summary

ManpowerGroup in Malaysia seeks a Validation Engineer to support remediation activities and lead validation documentation efforts. You will develop and execute protocols for IPM, TMV, IQ/OQ/PQ, and PC, ensuring alignment with design requirements and regulatory standards.

With 2-5 years of related experience and strong communication skills, you will collaborate with R&D, Quality, Regulatory, and Operations to deliver timely, compliant validation results and continuous process improvements.

Qualifications

• Bachelor’s degree in engineering, preferably Biomedical, Mechanical, or Chemical.
• 2-5 years of related field experience.
• Experience authoring and executing validation protocols and preparing validation reports.
• Excellent written and verbal communication with cross-functional teams.
• Understanding relationship between design requirements, risk management, design controls, and validation documentation.

Responsibilities

• Support global remediation initiatives by executing manufacturing validation remediation activities.
• Review, update, and remediate validation documentation (IPM, TMV, OQ/PQ, PC).
• Develop, author, and execute validation protocols per quality and regulatory requirements.
• Analyze validation data and prepare comprehensive validation reports.
• Ensure validation activities align with design requirements, risk management documentation, and applicable regulatory standards.
• Assess existing validation documentation to identify gaps and implement compliant remediation solutions.
• Collaborate with R&D, Quality, Regulatory, and Operations to support remediation deliverables.
• Ensure 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 corrective actions to support project execution.
• Contribute to continuous improvement initiatives that enhance validation processes and documentation quality.

Skills

Validation lifecycle

IPM/TMV/IQ/OQ/PQ

Validation reports

Cross-functional communication

Education

Bachelor’s degree in engineering

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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 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

Benefits

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