Engineering Documentation

Engineering Documentation & Compliance Coordinator Reporting to: Lead Engineering Compliance Documentation 🚀

About the role
Do you enjoy bringing structure to complex technical information? Are documentation quality, compliance and continuous improvement topics you enjoy working on? We’re looking for an Engineering Documentation & Compliance Coordinator to join our Brussels site. As our capital project portfolio and lifecycle management activities continue to grow, you will play a key role in strengthening and structuring our engineering documentation practices. You will ensure that engineering records, historical project documentation, technical modifications and as-built information are accurate, traceable, properly maintained and readily accessible. Working closely with Engineering, Project Management, Quality and Compliance teams, you will contribute to robust documentation governance, GEP/GxP compliance, inspection readiness and sustainable engineering ways of working. 📂 Your responsibilities
• Engineering Documentation Management
• Documentation Governance & Engineering Ways of Working
• Compliance & Inspection Readiness 🎓

Your profile
Education & Experience
• Bachelor’s degree in Engineering, Information Management, Quality Management, Life Sciences, or a related discipline.
• Minimum 3 years of relevant experience in GMP documentation, project coordination, compliance, quality systems or a related field.
• Experience within a pharmaceutical, biotechnology, manufacturing or other regulated environment is highly desirable.
• Experience with engineering projects, validation, document control systems and/or technical archives is a strong asset. 🔎 Skills & Competencies
• Strong understanding of engineering documentation and records management principles.
• Familiarity with Good Engineering Practices (GEP) and GxP requirements.
• Knowledge of project lifecycle management.
• Experience with electronic Document Management Systems (eDMS), SharePoint and Microsoft Office.
• Ability to manage large volumes of technical information and documentation with a high level of accuracy.
• Fluent in English and Dutch or French.
• Strong organizational and planning skills.
• Excellent attention to detail and accuracy.
• Ability to work independently while managing multiple priorities.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Collaborative mindset and continuous improvement orientation. 💡 Why join us? This is a great opportunity to play a key role in strengthening the engineering governance and compliance framework of a growing and dynamic site. You will contribute directly to improving documentation quality, operational efficiency and inspection readiness, while helping to establish sustainable ways of working that support the long-term maintainability of our facilities. 💙 Our Company Prothya Biosolutions makes life-saving plasma medicines, and we are proud of that Every day, our colleagues go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position in a flexible and fast-growing company with an exciting history? At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the opportunity to contribute, grow, innovate and learn. 🎁

We offer
Prothya Biosolutions Belgium is part of an international biopharmaceutical group offering long-term career perspectives and investing actively in on-the-job development. In return for your contribution,

we offer
• A competitive salary
• Group and health insurance
• Meal vouchers and eco-cheques
• A Flex Reward Plan, giving employees the opportunity to personalize part of their compensation package
• An attractive holiday system exceeding statutory holidays
• Homeworking after a successful onboarding period of 3 months
• An inclusive working environment where mutual respect and diversity are valued
• Plenty of opportunities to grow, innovate and learn Ready for your next challenge? 🚀 👉 Are you moving along? Apply now