Manufacturing Process Engineer

ManpowerGroup; Seberang Perai; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Annual Leave

Medical and Hospitalisation Leave

SOCSO

EPF

EIS

Job summary

Jora Malaysia in Penang is seeking a Validation Engineer to support global remediation initiatives by executing manufacturing validation remediation activities, developing and executing validation protocols (IPM, TMV, OQ/PQ), and ensuring alignment with design requirements and regulatory standards.

Candidates should have a Bachelor's in engineering and 2-5 years of related experience, with strong communication skills and the ability to work with R&D, Quality, Regulatory, and Operations.

Qualifications

• Excellent written and verbal communication skills.
• Understanding of design requirements, risk management, design controls, and validation documentation.
• 2-5 years of working experience in related field.
• Bachelor’s degree in engineering, preferably Biomedical, Mechanical, or Chemical.

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 system and regulatory requirements.
• Analyze validation data and prepare comprehensive validation reports documenting results and conclusions.
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Operations) to support remediation deliverables.

Skills

Communication skills

Validation knowledge

Cross-functional collaboration

Risk management

Education

Bachelor’s degree in engineering

Tools

IPM

TMV

IQ/OQ/PQ

Process Characterization

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