Commissioning & Qualification Engineer

PQE Group; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

PQE Group is seeking a Commissioning & Qualification Engineer to support projects in Singapore. The role requires 5 to 8 years of CQV experience in the pharmaceutical or biotechnology industry and a Bachelor's degree in Chemical, Mechanical, or Process Engineering.

You will lead CQV activities, develop strategies, and ensure GMP and regulatory compliance in a fast-paced setting. Strong collaboration with cross-functional teams and excellent English communication are essential as you coordinate

Qualifications

• Bachelor's degree in Chemical, Mechanical, Process Engineering, or a related discipline.
• 5 to 8 years of Commissioning & Qualification (CQV) experience within the pharmaceutical or biotechnology industry.
• Proven hands-on experience in CQV field execution for capital projects.
• Solid knowledge of cGMP, ISPE guidelines, and Risk-Based Validation principles.
• Strong communication skills and ability to collaborate effectively with cross-functional teams.
• Professional proficiency in English.

Responsibilities

• Execute Commissioning & Qualification (CQV) activities for assigned systems and process areas.
• Draft and support the development of CQV strategies, test plans, and procedures.
• Coordinate day-to-day commissioning tasks with Engineering, Operations, QA, EHS, Automation, and external vendors.
• Prepare, review, and execute CQV protocols, test scripts, deviations, and change controls.
• Ensure all activities comply with cGMP, regulatory requirements, and company quality standards.
• Track and report progress, field issues, and project milestones to the CQV Lead.

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Commissioning & Qualification Engineer with a strong experience in pharma sector to support our projects in Singapore.

Key Responsibilities:

• Execute Commissioning & Qualification (CQV) activities for assigned systems and process areas.
• Draft and support the development of CQV strategies, test plans, and procedures.
• Coordinate day-to-day commissioning tasks with Engineering, Operations, QA, EHS, Automation, and external vendors.
• Prepare, review, and execute CQV protocols, test scripts, deviations, and change controls.
• Ensure all activities comply with cGMP, regulatory requirements, and company quality standards.
• Track and report progress, field issues, and project milestones to the CQV Lead.

About You:

• Bachelor's degree in Chemical, Mechanical, Process Engineering, or a related discipline.
• 5 to 8 years of Commissioning & Qualification (CQV) experience within the pharmaceutical or biotechnology industry.
• Proven hands-on experience in CQV field execution for capital projects.
• Solid knowledge of cGMP, ISPE guidelines, and Risk-Based Validation principles.
• Strong communication skills and ability to collaborate effectively with cross-functional teams.
• Professional proficiency in English.

Experience in one or more of the following areas is highly desirable:

• HVAC & Cleanrooms
• Drug Linker / API Manufacturing
• Thermal Mapping
• Laboratory & Analytical Systems

First Project you will be assigned to:

Availability: Full on-site

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.