PERSOLKELLY Malaysia Hiring! Full Time Medical Devices : Validation Engineer in Johor, Earn up to MYR 6,000 - Ricebowl

Position : Validation Engineer

Industry: Medical device manufacturing and biotechnology consumables

Location: Kawasan Perindustrian SILC, 79200 Iskandar Puteri, Johor

Contract: 6 months via PERSOL (convert to permanent based on performance)

Working Hours: Monday to Friday (9:00 AM – 6:00 PM)

Key Responsibilities

• 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

Requirements

• 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

How to Apply?

Serious applicants may send their resumes to *************

#CWSA

Job Types: Full-time, Contract
Contract length: 6 months

Pay: RM4,000.00 - RM6,000.00 per month

Benefits:

• Professional development

Application Question(s):

• How soon you can start work?
• Reason for leaving current role
• Are you ok with 6 months contract role?

Education:

• Bachelor's (Preferred)

Experience:

• medical device or consumables: 3 years (Preferred)
• Validation Engineering: 3 years (Preferred)

Language:

• Mandarin (Preferred)

Work Location: In person