Validation Engineer (MNC/pharmaceutical)

RRECRUITER INT PTE. LTD.; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

RRECRUITER INT PTE. LTD. is seeking a CQV/Validation professional to execute CQV activities for GMP environments in Singapore.

The role involves preparing validation plans, IQ/OQ/PQ protocols, test scripts, and reports, and ensuring data integrity throughout the project lifecycle. You will validate equipment, utilities, facilities, and computerized systems, while coordinating with engineering, QA, clients, and vendors.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
• 3–5 years CQV/validation experience in pharmaceutical or biopharmaceutical industries.
• Strong documentation, analytical, problem-solving, and communication skills.
• Experience with equipment, utilities, cleanrooms, HVAC, water systems, or CSV is preferred.

Responsibilities

• Execute CQV activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.
• Prepare and review validation documents, including plans, IQ/OQ/PQ protocols, test scripts, and reports.
• Support validation of equipment, utilities, facilities, and computerized systems in compliance with GMP, GAMP 5, and 21 CFR Part 11.
• Coordinate with Engineering, QA, clients, and vendors on validation activities.
• Conduct risk/impact assessments, deviation investigations, and CAPA.
• Support FAT, SAT, commissioning, and qualification of new equipment and systems.
• Maintain accurate validation records and data integrity.

Skills

CQV

Validation

Documentation

Communication

Education

Bachelor's Degree

Tools

GAMP 5

21 CFR Part 11

Job description

Key Responsibilities

• Execute CQV activities for GMP-regulated pharmaceutical and biopharmaceutical facilities.

• Prepare and review validation documents, including plans, IQ/OQ/PQ protocols, test scripts, and reports.

• Support validation of equipment, utilities, facilities, and computerized systems in compliance with GMP, GAMP 5, and 21 CFR Part 11.

• Coordinate with Engineering, QA, clients, and vendors on validation activities.

• Conduct risk/impact assessments, deviation investigations, and CAPA.

• Support FAT, SAT, commissioning, and qualification of new equipment and systems.

• Maintain accurate validation records and data integrity.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.

• 3–5 years of CQV/validation experience in pharmaceutical or biopharmaceutical industries.

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

• Experience with equipment, utilities, cleanrooms, HVAC, water systems, or CSV is preferred.

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