CQV Engineer

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

ALL JOBS LISTED ARE BASED IN SINGAPORE ONLY.

FOR SINGAPOREAN ONLY. Job description:

ALL JOBS LISTED ARE BASED IN SINGAPORE ONLY. FOR SINGAPOREAN ONLY. Job description:

ALL JOBS LISTED ARE BASED IN SINGAPORE ONLY. FOR SINGAPOREAN ONLY. Job description:

• Lead Commissioning, Qualification & Validation (CQV) activities
• Lead a team and execute all field work such as Commissioning, Installation & Operational Qualification (IQ/OQ), Validation for downstream process equipment, CIP & Clean utilities to complete assigned tasks on time, on budget and safely while adhering to quality and engineering standards.
• Write and review project design documents (P&IDs, PFDs, URS, data sheets etc.), GMP/GDP documents and technical specifications, protocols preparation, execution and follow-up.
• Review and follow-up the technical documentation from the early design phase in order to align it with GMP and C&Q requirements
• Preparation and review of FAT, Commissioning and SAT protocols.
• Support the preparation of the final reports to the end-user
• Perform risk analysis and review performance progress.
• Support the preparation of the final reports to the end-user
• Coordinate with vendor & contractors to achieve streamlined CQV.
• To perform other related duties as assigned by management

Requirements:

• Degree in Engineering/Science related discipline.
• Minimum 5 years’ relevant experience in commissioning and qualification activities for construction projects in pharmaceutical facilities.
• Thorough knowledge of pharmaceutical guidelines e.g. GMP, GDP, ASTM E2500-07, FDA, ICH, ISPE and CQV practices.
• Candidates with senior experiences will be considered for a senior role.