CQV Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Coalesce Management Consulting seeks a CQV Engineer focused on Quality Control for a pharmaceutical client in Singapore. The role centers on qualifying GMP laboratory equipment, managing lifecycle activities, and ensuring compliant operations across the organization.

You will collaborate with cross-functional teams, lead root cause analyses, author Quality Notifications, and mentor colleagues to uphold high standards of safety, quality, and efficiency in GMP laboratories.

Qualifications

• Qualification/requalification/relocation/decommissioning of GMP lab equipment.
• Experience in GMP environments within pharmaceutical/chemical manufacturing.
• Work with cross-functional teams to ensure lifecycle alignment and compliance.

Responsibilities

• Perform/review system qualification, requalification, relocation, decommissioning and retirement for laboratory equipment.
• Act as Subject-Matter-Expert of laboratory system lifecycle across cross-functional teams.
• Author/review Quality Notifications and Test Exception Reports; lead root cause analysis.
• Troubleshoot laboratory system lifecycle issues impacting business and compliance.
• Identify opportunities to improve efficiency and compliance; provide leadership and training to team.

Skills

Root cause analysis

GMP

Regulatory compliance

Lab equipment qualification

Cross-functional collaboration

Education

Diploma or Bachelor’s degree in Chemical Engineering

Job description

We are looking for a CQV Engineer focusing on Quality Control for our client who is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission.

Primary Responsibilities:

• Perform/review system qualification, requalification, relocation, decommissioning and retirement for laboratory equipment in accordance with approved procedures and standard lead time.
• Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with cross-functional teams and above-site functions. This includes initiating alignments proactively, sharing expertise, and providing input to ensure alignment and consistency across the organization.
• Author/review Quality Notifications and Test Exception Reports, lead root cause analysis and ensure effective implementation of related actions within the agreed timeframe.
• Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency and compliance.
• Identify opportunities and propose solutions to improve efficiency and compliance in processes, standards, and best practices within the team.
• Provide leadership, expert guidance and support to team members, acting as a go-to resource for problem-solving and decision-making.
• Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Any other duties as assigned by reporting manager

Requirements:

• Diploma or bachelor’s degree in chemical engineering or any other relevant engineering field
• At least 5 years of experience in qualification, requalification, relocation, decommissioning and retirement of Good Manufacturing Practice (GMP) Lab equipment (not limited to Ultraviolet Visible (UV-Vis) Spectrometer, Total Organic Carbon (TOC) Analyzer, Microplate Reader, Liquid Particle Counter, Capillary Electrophoresis (CE), High-Performance Liquid Chromatography (HPLC), Analytical Balances, Incubators, Particle Counters)
• Experience in GMP environment within the pharmaceutical/chemical manufacturing.