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Validation and Compliance Project Engineer | Life Sciences
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Full-time
bachelor degree, postgraduate degree
Continuous Feedback, Quarterly Check-ins, FlexAbroad (Work abroad up to 45 days), Digital Campuses And Academy, Training Programs
Posted 27d ago
~40 hrs/week
Responsibilities
The Validation Engineer ensures pharmaceutical manufacturing processes, equipment, and cleaning procedures meet regulatory and quality standards. Key duties include executing IQ/OQ/PQ protocols, developing validation documentation, and leading investigations into deviations via CAPA.
Requirements
Candidates must have a Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, or Chemistry with 2-5 years of experience in life sciences validation. Fluency in both Dutch and English and strong knowledge of GMP and FDA/EMA regulations are required.
Full job description
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
As a Validation Engineer, you will play a crucial role in ensuring pharmaceutical manufacturing processes, equipment, and cleaning procedures meet regulatory requirements and quality standards. Working with cross-functional teams, you'll help our clients maintain compliance while optimizing their validation processes.
In this role you will play a key role in:
Executing validation protocols including IQ/OQ/PQ for equipment and process validation batches
Developing and reviewing cleaning validation documentation, performing risk assessments and worst-case analyses
Preparing validation master plans, protocols, and comprehensive validation reports
Collaborating with engineering, production, and quality teams to ensure validation activities align with GMP requirements
Supporting regulatory inspections and audits by providing validation documentation and expertise
Leading investigations related to deviations and implementing CAPA (Corrective and Preventive Actions)
Maintaining validation lifecycle documentation and performing impact assessments for changes
Your Profile
Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related technical field
Fluency in Dutch and English
2-5 years of experience in validation within the pharmaceutical or life sciences industry
Hands-on experience with equipment qualification (IQ/OQ/PQ), cleaning validation, and/or process validation
Strong knowledge of GMP regulations, FDA/EMA requirements, and industry validation standards
Experience with risk assessment methodologies and contamination control strategies
Excellent analytical skills with ability to interpret validation data and prepare technical reports
Strong communication and collaboration skills to work effectively in cross-functional teams
What You'll Love About Working Here
Continuous feedback: We take human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.
FlexAbroad: Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.
Digital campuses and academy: Our engineering academy offers more than 60,000 hours of training, as also our digital campus on GenAI, data or sustainability, support digital learning in the flow of work from awareness to expert certifications.
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.
Capgemini is an AI-powered global business and technology transformation partner, delivering tangible business value. We imagine the future of organizations and make it real with AI, technology and people. With our strong heritage of nearly 60 years, we are a responsible and diverse group of 420,000 team members in more than 50 countries. We deliver end-to-end services and solutions with our deep industry expertise and strong partner ecosystem, leveraging our capabilities across strategy, technology, design, engineering and business operations. The Group reported 2025 global revenues of €22.5 billion.
Make it real | www.capgemini.com
Offices: Place de l'Étoile, 11 rue de Tilsitt, Paris, France 75017, FR · Hullenbergweg 294, Amsterdam, North Holland 1101 BV, NL · 1601 Bryan St, Dallas, TX 75201, US · 595 Collins St, Melbourne, VIC 3000, AU · Fauststraat 3, Apeldoorn, Gelderland 7323 BA, NL
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How many Consulting jobs are open in Machelen, Belgium right now?
There are currently 189 open consulting positions in Machelen, Belgium listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Consulting roles in Machelen, Belgium?
Companies currently hiring include Capgemini, EY, Projective Group, Devoteam, NTT DATA, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Consulting jobs in Machelen, Belgium?
Yes — 169 of the 189 open consulting positions offer remote or hybrid work (1 remote, 168 hybrid).
How do I apply for Consulting jobs in Machelen, Belgium?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.