Senior CQV Engineer

LANYOU TECH PTE. LTD.; Singapore; On-site; SGD 100,000 - 180,000; Full time

Job summary

PVH (Tommy Hilfiger/Calvin Klein) seeks a CQV Engineer to lead commissioning, qualification, and validation of CU/Cleanroom and temperature controlled process systems in a regulated environment. You will ensure systems are installed, tested, and qualified in line with cGMP, USP/EP, and project standards.

The role requires 8 years of CQV experience in pharma/biotech, strong documentation skills, and the ability to coordinate with cross-functional teams to meet project milestones.

Qualifications

• Bachelor's degree in engineering, life sciences, or related discipline.
• 8 years of CQV experience in pharma/biotech.
• Strong knowledge of GMP, USP/EP, ISPE Baseline Guides, ASTM E2500, Annex 15.
• Strong problem-solving, documentation, and stakeholder communication skills.
• Ability to work independently and in cross-functional teams.
• Chinese language proficiency is preferred.

Responsibilities

• Commission, qualify, and validate CU/Cleanroom/Temperature Controlled Unit/Process systems to ensure regulatory compliance.
• Coordinate with cross-functional teams to ensure timely installation, testing, and qualification activities.
• Develop and execute commissioning and qualification protocols and reports; document results and deviations.
• Maintain traceability and ensure documentation is audit-ready.

Skills

Problem solving

Documentation

Stakeholder communication

Education

Bachelor's Degree in Engineering/Life Sciences

Job description

Overview

The CQV Engineer is responsible for the commissioning, qualification, and validation of CU/Cleanroom/Temperature Controlled Unit/Process systems. The role ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

Responsibilities

• Commission, qualify, and validate CU/Cleanroom/Temperature Controlled Unit/Process systems to ensure regulatory compliance and project standards.
• Coordinate with cross-functional teams to ensure timely installation, testing, and qualification activities.
• Develop and execute commissioning and qualification protocols and reports; document results and deviations.
• Maintain traceability and ensure documentation is accurate, complete, and audit-ready.

Qualifications

• Bachelors Degree in Engineering, Life Sciences, or related discipline
• 8 years experience of CQV in pharmaceutical / biotech industry.
• Strong knowledge of GMP guidelines, USP/EP, ISPE Baseline Guides, ASTM E2500, and Annex 15.
• Strong problem-solving, documentation, and stakeholder communication skills.
• Ability to work independently and as part of a cross-functional project team.
• Chinese language proficiency is preferred