Validation Engineer

About the Role

We are seeking a Validation Engineer to support validation and CQV activities for pharmaceutical and biopharmaceutical projects. The successful candidate will be responsible for ensuring equipment, facilities, utilities, and systems are validated in accordance with GMP requirements and regulatory standards while supporting project delivery from commissioning through operational readiness.

Responsibilities

• Execute commissioning, qualification, and validation (CQV) activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.

• Prepare, review, and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, test scripts, and validation reports.

• Perform validation of equipment, utilities, facilities, and computerized systems in compliance with GMP, GAMP 5, FDA 21 CFR Part 11, and applicable regulatory requirements.

• Coordinate with project engineers, quality assurance, clients, contractors, and vendors to ensure validation activities are completed according to project schedules.

• Conduct risk assessments, impact assessments, deviation investigations, and implement appropriate corrective and preventive actions (CAPA).

• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and qualification activities for new or modified equipment and systems.

• Ensure validation records are complete, accurate, and maintained in accordance with company quality procedures and data integrity requirements.

• Provide technical support throughout the design, construction, commissioning, and validation phases of pharmaceutical projects.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.

• 3–5 years of validation/CQV experience within the pharmaceutical or biopharmaceutical industry.

• Must have working experience in the construction industry.

• Good knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data integrity requirements.

• Experience with validation of equipment, utilities, cleanrooms, HVAC, water systems, or computerized systems will be an advantage.

• Strong documentation, analytical, and problem-solving skills.

• Excellent communication and coordination skills with the ability to work effectively in a multidisciplinary project environment.

• Able to communicate in Mandarin to liaise with Mandarin-speaking clients, contractors, suppliers, and project stakeholders where required.
  

  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