At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Your role
In this role, you will oversee qualification and compliance activities for facilities, utilities, and process equipment in advanced cell therapy manufacturing. You will play a key role in ensuring that critical production assets remain in a validated and compliant state while supporting quality excellence in a highly regulated environment.
In this role you will play a key role in:
* Collaborating with Asset Management and Engineering teams to maintain critical production assets in a validated and compliant state
* Evaluating and investigating deviations related to equipment issues with potential quality or compliance impact
* Reviewing and approving change controls while partnering with manufacturing teams
* Managing compliance status of production assets through review of calibration rationales, maintenance plans, and data integrity deliverables
* Approving qualification documentation including protocols, reports, rationales, SOPs, and user requirement specifications
Your profile
* Bachelor's degree in engineering (chemistry, analytical orientation), pharmaceutical sciences, or equivalent
* 4-6 years of experience in quality assurance, preferably in pharmaceutical or cell therapy manufacturing
* Strong awareness of quality principles and familiarity with cGMP regulations and FDA/EU guidance
* Experience with computerized systems, system configurations, and data management in critical production environments
* Excellent analytical thinking, risk assessment capabilities, and clear communication skills
What you'll love about working here
* Flexible work arrangements: Work from home up to 70% of the time, plus our FlexAbroad program lets you work up to 45 days from another country for better work-life balance
* Career development: Access diverse growth programs and career paths designed to help you explore new opportunities
* Inclusive community: Join employee-led networks like OUTfront, Women@Capgemini, or CapAbility that promote diversity, equity, and inclusion in our workplace and beyond
About Capgemini
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fuelled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.