CQV Engineer – Pharmaceutical / Biotech Facilities [ Commissioning, Qualification, and Validation ]

GOOD JOB CREATIONS (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical solutions provider in Singapore is seeking a CQV Specialist to manage commissioning, qualification, and validation activities in biotech manufacturing. Candidates should have at least 3 years of relevant experience and a Bachelor's degree in Engineering or Life Sciences. The role involves developing CQV protocols, coordinating with various teams, and ensuring compliance with regulations. This is a great opportunity for those looking to advance their careers in a dynamic environment.

Qualifications

• 3 years of experience in commissioning, qualification, or validation.
• Familiar with GMP, GAMP 5, ISPE Baseline Guides.
• Hands-on experience with utilities or process equipment.

Responsibilities

• Plan and manage CQV activities for biotech manufacturing.
• Develop and review CQV protocols and reports.
• Coordinate with engineering and quality teams.

Skills

Commissioning

Qualification

Validation

GMP knowledge

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

WFI

HVAC

Cleanroom systems

Job description

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.
• Perform any other ad-hoc tasks assigned by management.

Requirements:

• 3 years of experience in commissioning, qualification, or validation in pharmaceutical or biotech industries.
• 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.
• Bachelor’s degree in Engineering, Life Sciences, or related field.

We are an equal opportunities employer and welcome applications from all qualified candidates.