Batch Record Reviewer 1
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
We are seeking a detail-oriented MBR Qualification Engineer to join our team. The successful candidate will be responsible for qualification testing, writing, and executing test protocols for Master Batch Records (MBRs) within the PAS-X Manufacturing Execution System (MES).
Key Responsibilities
- Develop and write comprehensive test protocols for MBRs in PAS-X MES.
- Execute qualification testing for MBRs to ensure compliance with GMP and regulatory standards.
- Document and report test results, including any deviations or issues encountered during testing.
- Collaborate with cross-functional teams to resolve issues and ensure successful qualification of MBRs.
- Maintain accurate and up-to-date documentation of all qualification activities.
- Participate in continuous improvement initiatives to enhance the qualification process.
Your profile
- Bachelor’s degree in Medical or Scientific Engineering, Computer Science, or a related field.
- Experience in qualification testing and protocol writing within a pharmaceutical or biotechnology environment.
- Knowledge of PAS-X MES and Kneat is a plus.
- Familiarity with GMP and other regulatory requirements.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Excellent communication skills in English & Dutch.
What You Will Love About Working Here
- At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
- Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- OUTfront, Women@Capgemini or CapAbilityare 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.
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.
Diegem, BE