Validation Engineer
Summary
Validation Engineer ensures GMP-compliant commissioning, qualification, and validation of pharmaceutical facilities and systems, preparing protocols and reports while maintaining data integrity.
About the Role
We are seeking a CQV / Validation Engineer to support commissioning, qualification, and validation activities for GMP-regulated pharmaceutical and biopharmaceutical facilities. The role will work closely with engineering, quality, client, and vendor teams to ensure systems and equipment meet regulatory, quality, and data-integrity requirements.
Job Scope
Execute commissioning, qualification, and validation activities for facilities, equipment, utilities, cleanrooms, and computerized systems.
Prepare and review Validation Plans, IQ/OQ/PQ protocols, test scripts, summary reports, and related validation documents.
Support FAT, SAT, commissioning, system turnover, and qualification activities for new or modified equipment and systems.
Coordinate validation deliverables with project engineers, QA teams, clients, vendors, and other project stakeholders.
Conduct risk assessments, impact assessments, deviation investigations, and CAPA follow-up.
Ensure validation activities comply with GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and company quality procedures.
Maintain complete and accurate validation records and ensure data integrity throughout the system lifecycle.
Identify validation issues and support the implementation of appropriate corrective and preventive actions.
Requirements
Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
Approximately 3–5 years of relevant CQV or validation experience in the pharmaceutical or biopharmaceutical industry.
Good knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data-integrity principles.
Experience validating equipment, utilities, HVAC systems, water systems, cleanrooms, or computerized systems is preferred.
Familiar with IQ, OQ, PQ, FAT, SAT, deviations, CAPA, and risk-assessment processes.
Strong technical documentation, analytical, and problem-solving skills.
Good communication and coordination skills, with the ability to work effectively in a multidisciplinary project environment.
If interested, please submit your application to [email protected] with your expected salary and resume.
We regret that only short-listed candidates will be contacted shortly. By submitting your application or resume, you agree to the collection, use, retention, and sharing of your personal information with potential employers for their assessment.
JDA WMS Pte Ltd | EA Personnel: Pham Thi Tuyet Mai
EA License No: 23S1595 | EA Registration No: R25127838