Validation Engineer

Job Responsibilities

1. To develop and revise validation protocols, procedures and standard ISO documentation to ensure alignment with industry standards and best practices and present to sales/ customers.

2. To develop and maintain project activity/timeline/progress charts.

3. To perform calibration and verification of master instrument and equipment/accessories according to established procedures and protocols.

4. To calibrate and adjust master instrument as necessary to ensure accuracy and precision in measurement readings.

5. To document validation activities, including test results, observations, and any deviations from specifications, in accordance with regulatory requirements and company policies.

6. To troubleshoot and diagnose equipment malfunctions or performance issues, collaborating with technical experts or manufacturer as needed to resolve problems.

7. To maintain validation records and documentation in an organized and accessible manner for audit and regulatory compliance purposes.

8. To coordinate with other departments, such as quality assurance, calibration services, and engineering, to support validation activities and address cross-functional requirements.

9. To participate in any external audits, inspections, and quality assurance activities to assess compliance with regulatory requirements and quality standards.

10. To provide technical support and guidance to other team members or departments on validation-related issues or requirements.

11. To stay informed about industry trends, developments, and regulatory changes related to validation practices and requirements.

12. To perform any other duties as determined by the Management, which is considered beneficial to the Company and within your capabilities, without detriment or bringing injury to yourself.

Job Requirements

1. Bachelor’s degree in engineering, Science, or related field; relevant certifications or training in validation practices may be preferred.

2. Minimum of 1-2 years of experience in a validation technician or similar role, preferably in a calibration servicing company or regulated industry.

3. Fresh graduates with good scores can be considered.

4. Knowledge of validation principles, practices, and regulatory requirements, such as FDA regulations, HACCP, WHO, or Good Manufacturing Practices (GMP).

5. Familiarity with measurement instruments, equipment, and calibration procedures.

6. Strong attention to detail and analytical skills, with the ability to troubleshoot technical issues and interpret test results.

7. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

8. Proficiency in documentation and record-keeping, with experience in maintaining accurate and compliant records.

9. Ability to work independently with minimal supervision and prioritize tasks in a fast-paced environment.

10. Willingness to continuously learn and stay updated on industry developments and best practices in validation.