Validation Engineer

TSTAR RECRUIT PTE. LTD.; Singapore; On-site; SGD 40,000 - 67,000; Full time

Benefits offered by this job

AWS

VB (1-2 months)

Job summary

TSTAR RECRUIT PTE. LTD. is partnering with a multinational to recruit a Validation Engineer with 3–5 years of CQV experience in pharma/biopharma. The role covers CQV execution, documentation, and regulatory compliance across equipment, utilities, and systems.

The ideal candidate will have a bachelor’s degree in engineering or life sciences, strong GMP knowledge, and excellent documentation and communication skills for multidisciplinary projects.

Qualifications

• Bachelor’s degree in engineering, life sciences, pharmaceutical sciences, or related field.
• 3–5 years of validation/CQV experience in pharma/biopharma.
• Familiarity with GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data integrity.

Responsibilities

• Execute CQV activities for GMP-regulated pharma/biopharma facilities.
• Prepare and review validation documents: Validation Plans, IQ/OQ/PQ, protocols, reports.
• Support validation of equipment, utilities, facilities, and computerized systems.
• Coordinate with engineers, QA, clients, and vendors to meet deadlines.
• Conduct risk/impact assessments and deviations, implement CAPA.
• Ensure compliance with regulatory requirements and quality standards.
• Support FAT, SAT, commissioning, and qualification of new equipment.
• Maintain accurate documentation and data integrity throughout validation.

Skills

GMP knowledge

Documentation

Analytical thinking

Communication

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Our esteemed client, an established MNC, is searching for a Validation Engineer:

Job Responsibilities:

• Execute commissioning, qualification, and validation (CQV) activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.
• Prepare and review validation documentation, including Validation Plans, IQ/OQ/PQ protocols, test scripts, and final reports.
• Support the validation of equipment, utilities, facilities, and computerized systems in compliance with GMP, GAMP 5, and 21 CFR Part 11 requirements.
• Coordinate with project engineers, QA teams, clients, and vendors to ensure timely completion of validation deliverables.
• Conduct risk assessments, impact assessments, and deviation investigations, and implement appropriate CAPA.
• Ensure all validation activities comply with applicable regulatory requirements and company quality standards.
• Support FAT, SAT, commissioning, and qualification activities for new equipment and systems.
• Maintain accurate documentation and ensure data integrity throughout the validation lifecycle.

Job Requirements:

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
• 3–5 years of relevant validation/CQV experience in the pharmaceutical or biopharmaceutical industry.
• Good knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU GMP, and data integrity requirements.
• Experience with equipment, utilities, cleanrooms, HVAC, water systems, or computerized system validation is preferred.
• Strong documentation, analytical, and problem‑solving skills.
• Good communication skills with the ability to work effectively in a multidisciplinary project environment.

Additional Information:

• Salary:Up to SGD 6,000 +AWS+VB (1-2 Months)
• Working Location:Central
• Working Hours:5 Days Work, Mon-Fri: 8am-5pm
• Company pick up at Lakeside MRT Station

*We regret that only shortlisted candidates will be notified*