CQV Engineer

Role Overview

We are looking for a CQV Engineer to support performance qualification (PQ) and validation activities for isolators, lyophilizers, and aseptic operations. The role covers VHP PQ, Isolator PQ, Aseptic Process Simulation (APS), and Lyophilizer Performance Runs. The candidate will work closely with Manufacturing, Validation, QC, Engineering, and third-party labs to ensure successful execution.

Key Responsibilities

• Develop and execute PQ/validation protocols, strategies, and reports (Isolator, Lyophilizer, APS, VHP).
• Coordinate with internal teams and external labs for sample management, testing, and reporting.
• Support execution of APS and performance runs, including interventions, filling, stoppering, capping, and lyo operations.
• Provide technical input and ensure compliance with cGMP and regulatory requirements.

Requirements

• Experience in VHP decontamination and fill-finish/aseptic operations.
• Familiar with drug product manufacturing and aseptic simulations (media fills preferred).
• Strong troubleshooting, problem-solving, and technical writing skills.
• Ability to work in a fast-paced, multi-tasking environment with evolving needs.
• Excellent communication and coordination skills.

What we offer

At Coalesce Management Consulting Pte. Limited, we are committed to providing our employees with a supportive and rewarding work environment. We offer competitive remuneration, opportunities for career growth and development, and a range of benefits to support your wellbeing. Join our dynamic team and contribute to the success of our clients projects.