Quality Assurance Analyst III - Asset Engineer

Описание вакансии

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Analyst III - Asset Engineer to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Ghent office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

This position is part of the CAR-T Asset Engineering team within the Make Asset Management organization (MAM). The Asset Engineer provides technical expertise for lab and process equipment used in the CAR-T process and supports Commissioning and Qualification (C&Q) activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants serving Ghent and Beerse sites. The role is a key contributor to reliable operations and execution of asset lifecycle management projects in close collaboration with project teams, vendors, site partners, and other stakeholders. As an Asset Engineer you lead consistent technical management and implementation of equipment, ensuring compliance with Company global and local standards & processes.

Main Job Tasks and Responsibilities:

• Manages multiple business requests and/or small projects equipment-related through change control quality system.
• Support and execute operational C&Q activities, ensuring deployment aligns with our Global processes.
• Serve as the Asset Subject Matter Expert (SME) for CAR-T equipment.
• Contribute to the creation and review of asset technical requirements and standards.
• Provide guidance on compliance and data integrity requirements.
• Identify and assess gaps between Global and local compliance processes and drive consistent, compliant CAR-T technical practices across CAR-T sites.
• Develop and maintain strong strategic vendor relationships.
• Sustain continuous technical improvements across the asset base.
• Drive to solutions by coordinating with other internal departments and/or outside suppliers.
• Support technical investigations arising during C&Q activities or day-to-day operations.
• Drive evaluation, business case development, and implementation of new asset technologies.

Education and Experience:

• A minimum of a Master’s Degree in Science, Engineering, Bioengineering or equivalent technical discipline is required.
• 3+ years of experience in in pharmaceutical manufacturing / engineering.
• Experience in commissioning & qualification (C&Q).
• Understanding on data integrity requirements (21 CFR Part 11).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Analyst Asset Engineer, CAR-T, Commissioning & Qualification (C&Q), Equipment, Data Integrity, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

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