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As a Process Validation Engineer, you will play a key role in ensuring the continued robustness, compliance, and performance of advanced cell therapy manufacturing processes across the EMEA region. Embedded within a Manufacturing Science & Technology (MSAT) organisation, you will support Continued Process Verification (CPV) activities and contribute to process monitoring, data trending, and validation lifecycle management in a highly regulated environment.
You will play a key role in:
- Supporting the preparation and issuance of Annual Stage 3 Continued Process Verification (CPV) reports by collecting, analysing, and consolidating process performance data from systems such as MES, LIMS, and SAP.
- Performing statistical analyses and routine trending using tools such as JMP or Minitab to monitor key process performance indicators, including cell viability, harvest yield, transduction efficiency, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs).
- Identifying process variability, emerging trends, and Out-of-Trend (OOT) conditions, escalating findings for further investigation and supporting root cause analysis activities.
- Assessing and documenting the current state of particle monitoring and governance, mapping sampling locations, analysing particulate monitoring data, and developing enhanced governance frameworks including alert levels, action limits, and response procedures.
- Collaborating with Quality Assurance, Manufacturing, Validation, and Technical Transfer teams to ensure compliance with cGMP requirements, data integrity principles, and applicable regulatory expectations throughout the process lifecycle.
- A Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmaceutical Sciences, or a related scientific discipline
- 5 to 7 years of experience in the pharmaceutical, biotechnology, cell therapy, or broader life sciences industry.
- Solid knowledge of process validation lifecycle principles, Continued Process Verification (CPV), and manufacturing process capability and control strategies, with experience in statistical trend analysis and process performance monitoring.
- Hands-on experience working with manufacturing and quality systems such as MES, LIMS, SAP, and QMS platforms, with the ability to extract, structure, and interpret complex datasets.
- A strong understanding of cGMP requirements, data integrity standards, deviation and CAPA processes, and regulatory expectations for pharmaceutical or cell therapy manufacturing environments.
- Fluency in both Dutch and English, combined with excellent communication, stakeholder management, and cross-functional collaboration skills.
- Mentoring programs: Capgemini empowers women 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.
- Global Tech challenges: Capgemini hosts annual group-wide competitions, such as the Global Data Science Challenge and Tech4PositiveFutures. These aim to address world issues like climate change and biodiversity by applying technology for innovative solutions. The Future of X is a Global Ideation Campaign that look for ideas for iconic anchor R&I projects and demonstrators of Technology. Winning ideas were funded up to 100K€.
- Career acceleration programs: From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.
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.
