Validation Engineer

PERSOL; Gelang Patah; On-site; MYR 89,000 - 167,000; Part time

Benefits offered by this job

EPF

SOCSO & EIS

Annual Leave

Medical Leave

Hospitalization Leave

Job summary

Jora Malaysia is seeking a Validation Engineer to support ISO 13485‑compliant validation activities in a medical device manufacturing setting. The role focuses on validating processes, equipment, and systems, ensuring documentation and regulatory compliance while maintaining high quality standards.

The position is a 6‑month contract through Persol, with potential conversion after six months, based on client decision.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related field.
• Minimum of 3–5 years of experience in a Validation Engineering role in ISO 13485 medical device or regulated manufacturing environment.
• Experience with process validation, equipment qualification, and regulatory compliance.
• Strong problem‑solving and analytical skills.
• Excellent verbal and written communication.

Responsibilities

• Execute ISO‑13485 compliant process validation and equipment validation.
• Develop and execute Validation Master Plans, Protocols, and Reports.
• Conduct risk assessments to identify critical process parameters.
• Validate manufacturing processes to ensure quality of consumables.
• Create and execute Process Performance Qualification studies.
• Collaborate with production and engineering to improve processes.
• Maintain detailed validation documentation and reports.
• Review validation documentation for regulatory compliance.
• Participate in audits and address corrective actions.
• Stay updated on validation techniques and standards.

Skills

Process validation

Equipment qualification

Regulatory compliance

Quality control principles

Data analysis

Education

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

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.

We are currently looking for suitable candidates for our client for a Validation Engineer role. This position will be responsible for supporting the development, implementation, and oversight of validation activities within an ISO 13485–compliant consumable manufacturing facility. The role focuses on validating manufacturing processes, equipment, and systems to ensure consistent compliance with regulatory, safety, and quality requirements. The successful candidate will play a key role in maintaining ISO 13485 compliance by ensuring all validation activities are properly documented, executed, and reported. Candidates should be comfortable working in a fast‑paced, mission‑driven environment and be ready to take on a wide range of challenges as the company continues to grow.

Position : Validation Engineer
Status : Contract 6 Months under PERSOL (Can be converted after 6 months upon client’s decision)
Location : Perindustrian SILC , Gelang Patah
Background : Medical Devices Manufacturing Company
Working Days : Monday – Friday
Working Hours : 9AM – 6PMSalary : Negotiable based on experience
Allowance : TBC
Entitlements: EPF, Socso & EIS, Annual Leave, Medical Leave, Hospitalization Leave
Public Holiday based on client.

Requirement

1. Bachelor's degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related field.
2. Minimum of 3-5 years of experience in a Validation Engineering or Validation Engineer role with ISO 13485-compliant medical device or regulated manufacturing environment experience.
3. Proven experience with process validation, equipment qualifi cation, and regulatory compliance.
4. Strong problem-solving and analytical skills.
5. Effective communication skills, both verbal and written.
6. Self-awareness, integrity, authenticity, and a growth mindset.
7. Strong understanding of quality control principles and supplier management practices.
8. Profi ciency in audit techniques, supplier performance tracking, and data analysis.
9. Familiarity with ISO-13485 Quality Management Systems (QMS).

Responsibilities

1. Execute process validation and equipment validation in accordance with ISO-13485 standards.
2. Assist in developing and executing Validation Master Plans (VMP), Validation Protocols, and Validation Reports for all validation activities.
3. Conduct risk assessments to determine critical process parameters and establish control limits for process validation and verification.
4. Validate manufacturing processes to ensure consistent production of consumables that meet established quality standards.
5. Assist in the creation and execution of Process Performance Qualification studies
6. Work closely with the production and engineering teams to identify areas for improvement in manufacturing processes, including optimizing parameters and ensuring robustness and consistency in results.
7. Maintain accurate and detailed records of validation activities, including protocols, reports, and supporting documentation.
8. Review and approve validation documentation and reports to ensure compliance with internal standards and regulatory requirements.
9. Participate in internal and external audits to assess the effectiveness of validation activities and ensure regulatory compliance.
10. Address findings from audits or inspections related to validation, ensuring that corrective actions are implemented and documented.
11. Participate in cross-functional teams to improve product quality, operational efficiency, and validation practices.
12. Stay up-to‑date with the latest developments in validation techniques, regulations, and industry standards.