QA Cleaning validation Engineer | Life Sciences

Capgemini -
Diegem

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1 dag geleden

Kwalificaties

Kwaliteitsborging
Documentmanagementsystemen
Nederlands

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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

We are looking for an experienced QA Cleaning Validation Engineer to support the QA Engineering department at a leading pharmaceutical manufacturing site in Geel. In this role, you will play a central part in ensuring that all cleaning validation activities meet the highest regulatory and procedural standards, working across multi-disciplinary teams in a dynamic and compliance-driven environment.

In this role you will play a key role in:

Reviewing and approving cleaning validation activities including SOPs, trend reports, protocols, and validation/verification reports, ensuring full alignment with cGMP regulations and internal quality standards
Participating actively in Change Controls related to cleaning processes, providing expert input and ensuring all changes are assessed, documented, and implemented in a compliant manner
Supporting and contributing to projects related to cleaning validation, monitoring, and cleaning verification, including the introduction of new or upgraded systems and processes
Reviewing and approving digital cleaning recipes within MES and PCS systems, leveraging your technical expertise to ensure accuracy, compliance, and operational efficiency
Acting as a key point of contact within multi-disciplinary teams, communicating clearly on quality, compliance, and planning status to stakeholders at all levels of the organisation, and providing guidance on cGMP aspects related to cleaning activities

Your profile

You bring 5 to 15 years of experience in the chemical and/or pharmaceutical industry, with a strong and demonstrable background in cleaning validation and quality assurance
You have solid knowledge of cGMP regulations and guidelines, and you are able to translate complex technical information into clear, accessible communication for all levels of the organisation
You are experienced working with digital cleaning recipe systems within MES and PCS environments, as well as problem report and change request systems (e.g. Comet) and document management systems (e.g. TruVault)
You are a collaborative team player who is equally comfortable working independently — you can manage multiple projects simultaneously, accurately assess urgency and impact, and thrive in a cross-functional environment
You are fluent in both English and Dutch (written and spoken), enabling you to communicate effectively across teams and with stakeholders at this Belgian site

What you'll love about working here

Passion for Sport Sport reflects our values of team spirit, diversity, and fun. From rugby to golf, we bring our technology, digital, and innovation expertise to our association with major sporting events around the world.

Mentoring Programs Capgemini empowers people at all career stages with programs spanning STEM education to career reentry. We value mentorship for fostering professional growth and empowerment within our engineering community.

FlexAbroad Employees in 20+ countries can work abroad for up to 45 days in a 12-month period — giving you the freedom to experience new places while continuing to do great work.

Well-being Hub The global Well-Being Hub connects employees across various facets of well-being: work-life balance, working hours, and network growth — because we know that when you feel good, you do your best work.

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 fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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