- North Bridge Road Downtown Core Central Region (Singapore) Singapore

Lokasi Kerja
Penerangan Kerja
Tanggungjawab
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.
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.
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 ************* 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
JDA WMS is a global leader in the world of recruitment and matching systems. Leveraging cutting-edge technologies, we bridge the gap between candidates' aspirations and organizations' needs. Our unparalleled expertise lies in delivering bespoke solutions, ensuring impeccable candidate job alignment.
With a strong emphasis on diversity, quality, and innovation, JDA WMS stands at the forefront of transforming recruitment landscapes worldwide, making every match count.
Website: *************
Phone: +************* 6568
If interested, please submit your application to ************* with your expected salary and resume.
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