Senior CQV Engineer — Pharma GMP/Validation Lead

Staffhub Group; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Staffhub Group is seeking a seasoned CQV Lead for pharmaceutical facilities in Singapore. You will head CQV activities, guide a project team, and manage IQ/OQ/Validation for critical downstream equipment and clean utilities.

The role requires hands-on protocol development, GMP/GDP familiarity, and strong coordination with vendors. Senior candidates may be considered for advanced responsibilities in a fast-paced, quality-driven environment.

Qualifications

• Bachelor's degree in Engineering/Science.
• Minimum 5 years’ experience in commissioning and qualification for pharmaceutical facilities.
• Thorough knowledge of GMP, GDP, ASTM E2500-07, FDA, ICH, ISPE and CQV practices.
• Senior candidates may be considered for a senior role.

Responsibilities

• Lead Commissioning, Qualification & Validation (CQV) activities and oversee field work.
• Lead a team and execute IQ/OQ, Validation for downstream process equipment, CIP & Clean utilities.
• Write and review P&IDs, URS, data sheets, GMP/GDP documents, protocols and related documentation.
• Review early design documentation to align with GMP and CQV requirements.
• Prepare and review FAT, Commissioning and SAT protocols; support final reports to the end-user.
• Perform risk analyses and monitor progress; coordinate with vendors and contractors for CQV.

Skills

CQV leadership

Commissioning & Qualification

P&IDs & URS

GMP/GDP knowledge

Documentation review

Education

Engineering/Science degree

Tools

FAT/SAT protocols

QA documentation tools

Job description

Staffhub Group is seeking a seasoned CQV Lead for pharmaceutical facilities in Singapore. You will head CQV activities, guide a project team, and manage IQ/OQ/Validation for critical downstream equipment and clean utilities.

The role requires hands-on protocol development, GMP/GDP familiarity, and strong coordination with vendors. Senior candidates may be considered for advanced responsibilities in a fast-paced, quality-driven environment.