Validation and Compliance Project Engineer | Life Sciences

Capgemini; Diegem; Hybride; EUR 52 000 - 76 000; Plein temps

Avantages offerts par ce poste

Hybrid working

Mentoring programs

Free learning platforms

Résumé du poste

Capgemini Engineering in Flanders, Belgium, seeks a Medior Project Engineer - Validation & Compliance to coordinate validation and verification activities within capital projects in a regulated pharmaceutical environment. You will act as the interface between Engineering and Quality Assurance to ensure safe, compliant project delivery.

You will apply GMP, ISO and ICH standards, draft validation protocols, support QRM, manage multiple projects, and contribute to process improvements.

Qualifications

• Master's degree in Engineering or a relevant scientific field.
• At least 2 years' experience in a regulated pharmaceutical or production environment.
• Fluent in Dutch and English with strong technical writing capabilities.
• Experience with aseptic processes, cleaning, disinfection, sterilisation is a plus.

Responsabilités

• Coordinate validation and verification activities across capital projects.
• Interpret GMP, ISO and ICH standards and liaise with QA for compliant delivery.
• Draft, review and manage validation protocols and qualification docs.
• Support Quality Risk Assessments and investigations; manage multiple projects.
• Provide backup support to fellow project engineers as needed.

Connaissances

Communication

Stakeholder management

Cross-functional collaboration

Technical writing

Project coordination

Attention to detail

Formation

Master's degree in Engineering / related field

Description du poste

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 RoleWe are looking for a Medior Project Engineer - Validation & Compliance to join our team in Flanders, Belgium. In this role, you will coordinate validation and verification activities within capital projects in a regulated pharmaceutical environment, acting as a key interface between Engineering and Quality Assurance to ensure safe, compliant, and efficient project delivery. In this role you will play a key role in:Coordinating validation and verification activities across capital projects, developing and monitoring project schedules from planning through to full implementation, ensuring all milestones are met with accuracy and compliance at the forefrontInterpreting and applying GMP regulations (US and EU), international standards (ISO, ICH), and internal quality standards, serving as the primary liaison between Engineering and Quality Assurance teams to maintain alignment throughout project lifecyclesDrafting, reviewing, and managing validation protocols, qualification documentation, and technical compliance documents, upholding the highest standards of technical writing and documentation accuracy at all timesFacilitating Quality Risk Assessments (QRM) and providing expertise in validation, verification, and risk management, as well as supporting investigations related to quality issues, deviations, and change control processesManaging one or more projects simultaneously, contributing to continuous improvement initiatives, supporting the introduction of new products, and addressing urgent quality investigations with a structured and solution-driven approachSupporting qualification and validation of analytical methods and contributing to the development of computer-controlled systems where applicable, while also providing backup support to fellow project engineers as neededYour ProfileYou hold a Master's degree in Engineering (Civil, Industrial, or Bio-engineering), Industrial Pharmacy, or a relevant scientific field such as Biochemistry, Biotechnology, or a related discipline — equivalent experience will also be consideredYou bring a minimum of 2 years of experience in a regulated pharmaceutical or production environment, with a solid understanding of GMP requirements and validation and qualification processesYou demonstrate strong communication and stakeholder management skills, with the ability to collaborate effectively across cross-functional teams, manage multiple priorities in a dynamic environment, and take ownership of your responsibilities with attention to detail and reliabilityYou are fluent in both Dutch and English, with excellent technical writing capabilities and a structured, detail-oriented working style that ensures accuracy and quality in every deliverableExperience with aseptic processes, cleaning, disinfection, sterilisation, or laboratory environments is a strong advantage and will be highly valuedWhat You Will Love About Working HereHybrid working – We encourage flexibility when it comes to when and where work gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.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.Free access to learning platforms – Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.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.