Commissioning, Qualification & Validation (CQV) Engineer | Life Sciences
Capgemini
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.
Job Description
As a CQV engineer, you will manage commissioning, qualification and validation at different phases in the process, from being in contact with the supplier to the validation and testing of the equipment.
Depending on your project, your role will be to
- Manage the commissioning, qualification and validation in different phases (start-up, qualification, etc.).
- Support the qualification and validation approach.
- Support equipment/process risk analysis (FMEA).
- Write qualification documents (protocols/test sheets/validation plan).
- Carry out Equipment Commissioning (FAT/SAT).
- Coordinate and perform qualification (IQ, OQ) tests.
- Manage and document deviations and non-conformities during test runs.
- Work in close cooperation with production, EHS, engineering, maintenance, QC, QA, etc.
- Ensure handover with end users.
Your Profile
- A Master's degree in Engineering or equivalent in experience.
- Professional level in English, fluent in French and/or Dutch is an asset
- Experience in a GMP environment.
- Knowledge of FDA, EMA, ICH, ASTM E2500, GAMP is a strong asset.
- A consultancy mindset
- Ready to jump in a new project, quickly gain the skills and knowledge needed to support your client, and seeing any challenge as an opportunity to (im)prove yourself.
- Socially fluent: build your professional network at both the client and Capgemini.
- Business acumen: Analyze and evaluate the client's organization to identify their challenges and needs, so we can offer them solutions.
- Knowledge capitalization: capture and share your knowledge and expertise with other consultants and make use of Capgemini's tools to boost yourself.
What we offer
- Within Capgemini, you will be part of a global company with endless opportunities, yet we offer a very individual and personal approach and follow-up of each consultant through small teams, led by dedicated Team Managers here in Belgium.
- Challenging and meaningful projects, attuned to your own skills and interests, at the most renowned pharmaceutical companies in the world.
- The entire knowledgebase and expertise of Capgemini to support you on your projects and develop your own skills through live trainings, e-learning platforms, knowledge sharing workshops, coaching by senior consultants, etc.
- An extensive and transparent career framework allowing you to plan and follow your own career path: whether you want to grow into a senior consultant/expert/architect or move into Team/Account/Solution/Project Management, we are here to help you achieve your maximum potential.
- A highly competitive and broad salary package, including company car with fuel/energy card.
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.