Total 3 job vacancies by Lanyou Tech Pte. Ltd.

Job Description

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.

Requirements

• Bachelors Degree in Engineering, Life Sciences, or related discipline
• Strong problem-solving, documentation, and stakeholder communication skills
• Ability to work independently and as part of a cross-functional project team
• It would be good if you know Chinese

1        KEY RESPONSIBILITIES

• Develop and execute validation (IQ/OQ/PQ) / study protocols as performer or witnessed by (depending on assignment) against approved URS and risk assessments. 
• Lead or support risk assessments and impact assessments where applicable.
• Initiate change control process for any modifications affecting validated state.
• Plan, manage and coordinate activities with other functions including equipment suppliers, Engineering, Manufacturing, QC, QA.
• Track the CQV deliverables and ensure adherence to schedule from project to operation readiness.
• Ensure traceability across lifecycle documents.
• Lead resolution of variation / deviation investigation in a timely and compliant manner.

2        SCOPE OF WORK

• Qualification of clean air equipment, such as VBE (ventilated balance enclosure / negative pressure hood) etc.
• Qualification of sterilization cycle (CD, PQ) of autoclave loads. 
• Qualification of temperature‑controlled unit.

Job Description

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.

Requirements

• 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.
• It would be good if you know Chinese