CQV Engineer

MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD. is seeking a CQV (Commissioning, Qualification & Validation) Engineer to support the validation of pharmaceutical/Biotech manufacturing facilities. Responsibilities include managing CQV activities and ensuring compliance with regulatory requirements.

The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences and 2–5 years of related experience. Familiarity with GMP and hands-on experience with utilities or cleanroom systems is highly preferred.

Qualifications

• 2–5 years of experience in commissioning/qualification/validation in pharmaceutical or biotech industries.
• Familiar with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations.
• Hands-on experience with utilities and process equipment preferred.

Responsibilities

• Plan, execute, and manage commissioning, qualification, and validation activities.
• Develop and review CQV protocols and reports.
• Coordinate with engineering, project, and quality teams.

Skills

Project coordination

GMP compliance

Troubleshooting

Communication skills

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

About the Role

Join our team as a CQV (Commissioning, Qualification & Validation) Engineer, supporting the start-up and validation of state-of-the-art pharmaceutical/biotech manufacturing facilities. You will work closely with project, engineering, and quality teams to ensure all systems meet GMP compliance and are ready for commercial production.

Job Responsibilities

• Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment.
• Develop and review CQV protocols (IQ/OQ/PQ) and reports in compliance with GMP, GAMP 5, and company procedures.
• Coordinate with engineering, project, and quality teams to ensure timely CQV execution.
• Troubleshoot and resolve CQV-related issues during project execution.
• Ensure adherence to regulatory requirements (e.g., FDA, EMA, PIC/S) and local health authority guidelines.
• Support FAT, SAT, and risk assessments for new or modified systems.
• Provide technical input during design, construction, and operational readiness stages.

Job Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 2–5 years of experience in commissioning/qualification/validation in pharmaceutical or biotech industries (senior roles may require 5+ years).
• Familiar with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations.
• Hands‑on experience with utilities (e.g., WFI, clean steam, HVAC), process equipment, or cleanroom systems preferred.
• Good communication and project coordination skills.