Validation and Compliance Project Engineer | Life Sciences

Capgemini; Town of Belgium (WI); On-site; USD 79,926 - 125,599; Full time

Benefits offered by this job

Hybrid working

Mentoring programs

Free learning platforms

Job summary

Capgemini Engineering is seeking a Medior Project Engineer for Validation & Compliance to coordinate validation activities in regulated pharma projects. You will liaise between Engineering and Quality Assurance, draft protocols, monitor schedules, and ensure GMP-aligned documentation throughout project lifecycles.

Your profile includes a Master's in engineering or related science, 2+ years in a regulated environment, and fluent Dutch and English with strong technical writing.

Qualifications

• Master's degree in engineering or related field is required.
• Minimum 2 years of experience in a regulated pharmaceutical or production environment with GMP.
• Fluent in Dutch and English with strong technical writing capabilities.
• Experience with aseptic processes, cleaning or sterilisation is a plus.

Responsibilities

• Coordinate validation and verification activities across capital projects, developing and monitoring schedules.
• Interpret and apply GMP regulations (US and EU), ISO and ICH standards, ensuring compliance.
• Draft, review, and manage validation protocols and qualification documents with rigorous documentation.
• Facilitate Quality Risk Assessments (QRM) and support investigations, deviations and change control.
• Manage one or more projects, contribute to continuous improvement, and support new product introductions.
• Assist qualification and validation of analytical methods and provide backup support to teammates.

Skills

GMP knowledge

Validation

Technical writing

Stakeholder management

Cross-functional collaboration

Education

Master's degree in engineering or related field

Job description

# Validation and Compliance Project Engineer | Life SciencesDiegemApply for this job* Permanent* Experienced Professionals* Quality Engineering & Testing* ID 517072-en\_GBAt 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 forefront + **Interpreting 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 lifecycles + **Drafting, reviewing, and managing** validation protocols, qualification documentation, and technical compliance documents, upholding the highest standards of technical writing and documentation accuracy at all times + **Facilitating 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 processes + **Managing 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 approach + **Supporting 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 needed## Your Profile* You 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 considered* You 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 processes* You 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 reliability* You 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 deliverable* Experience with **aseptic processes, cleaning, disinfection, sterilisation**, or laboratory environments is a strong advantage and will be highly valued## What You Will Love About Working Here* **Hybrid 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.