Your Role

We are looking for a Process Equipment Qualification Engineer to join our team in Beerse, supporting one of the world's leading pharmaceutical organisations. In this role, you will lead and execute qualification and validation activities for GMP-regulated manufacturing and packaging equipment, ensuring full compliance with regulatory requirements and internal quality standards throughout the equipment lifecycle.

In this role you will play a key role in:

• Leading and executing equipment qualification activities across the full project lifecycle, including development and review of URS, DQ, IQ, OQ, PQ, Traceability Matrices, and Qualification Summary Reports
• Performing risk assessments and impact analyses using risk-based qualification approaches in line with GAMP5 and EU GMP Annex 15
• Coordinating and participating in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), working closely with engineering teams and external vendors
• Supporting change control processes, deviation investigations, and CAPA activities to ensure ongoing compliance and continuous improvement
• Collaborating cross-functionally with Engineering, Manufacturing, Quality Assurance, and Maintenance teams to drive qualification programmes forward
• Providing technical support during audits and regulatory inspections, ensuring readiness and alignment with FDA, EMA, and GMP/GDP requirements

Your Profile

• You hold a Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, or a related technical discipline
• Minimum of 3 years of experience in a GMP-regulated pharmaceutical, biotech, or life sciences environment
• You have proven hands-on experience in equipment qualification and validation, with exposure to one or more of the following: bioprocessing equipment, CIP/SIP systems, fill-finish equipment, packaging equipment, reactors and mixing vessels, or automated production systems
• You bring strong knowledge of GMP/GDP requirements, ISPE guidelines, GAMP5 methodology, EU GMP Annex 15, and FDA regulations, and are comfortable applying risk-based approaches in your day-to-day work
• You are a clear and confident communicator with excellent documentation and technical writing skills, able to work both independently and as part of cross-functional teams in a fast-paced, regulated environment
• You are fluent in English and Dutch

What you'll love about working here

Digital campuses and academy Our engineering academy offers more than 60,000 hours of training, as well as our digital campus on GenAI, data or sustainability, supporting digital learning in the flow of work from awareness to expert certifications.

FlexAbroad Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.

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Life at Capgemini Engineering in Belgium

At Capgemini Engineering Belgium, we offer a stimulating and inclusive work environment where your growth and well-being are a priority. You'll benefit from:

• A competitive salary package with company car or mobility budget, meal vouchers, hospitalization and group insurance
• Flexible working arrangements, including hybrid working options
• A wide range of learning and development opportunities through our internal academies and external training programmes
• Access to our vibrant local engineering community, with regular knowledge-sharing events, tech talks, and team activities
• A diverse and welcoming culture where everyone is encouraged to bring their whole self to work