Coordinator Engineering Documentation Compliance | Brussels

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Neder-Over-Heembeek; On-site; EUR 52,000 - 78,000; Full time

Benefits offered by this job

Salary package and bonus potential

Health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

Homeworking after onboarding

Job summary

Prothya Biosolutions Brussels site is seeking an Engineering Documentation & Compliance Coordinator to establish and sustain a centralized governance framework for engineering documentation and as-built records. The role focuses on compliance, inspection readiness, and lifecycle management across projects and utilities.

Responsibilities include organizing records, supporting governance through WoW standards, and ensuring traceability and archiving in line with GMP and GEP/GxP requirements.

Qualifications

• Minimum Bachelor’s degree in engineering, Information management, Quality Management, Life Sciences, or related field.
• Minimum 3 years of experience in GMP documentation, project coordination, compliance, quality systems, or related field.
• Pharma/biotech/manufacturing regulated environment experience is highly desirable.
• Experience with engineering projects, validation, document control systems, and technical archives is a strong asset.

Responsibilities

• Establish, organize, and maintain a centralized repository for engineering and as-built documentation.
• Identify, collect, consolidate, and structure existing engineering records, historical project files, technical modifications, and facility documentation.
• Ensure the integrity, accuracy, accessibility, and traceability of engineering documentation throughout its lifecycle.
• Maintain historical engineering records for facilities, utilities, equipment, infrastructure, and site systems.
• Ensure as-built documentation is updated, archived, and controlled in accordance with site procedures and project requirements.
• Maintain the engineering department training plan and training documentation.

Skills

Documentation management

GEP & GxP knowledge

Project lifecycle management

Records management

Communication & stakeholder management

Education

Bachelor’s degree in engineering/IM/QM/Life Sciences

Tools

eDMS

SharePoint

Microsoft Office

Job description

Coordinator Engineering Documentation Compliance | Brussels

Engineering Documentation & Compliance Coordinator

Reporting to Supervisor Engineering Compliance Documentation

We are seeking a highly organized and detail-oriented Engineering Documentation & Compliance Coordinator to support the establishment of a robust engineering documentation governance framework across our Brussels site.

As the site continues to expand its capital project portfolio and lifecycle management activities, this role will be responsible for implementing and sustaining a centralized engineering documentation management process. The successful candidate will ensure that engineering records, historical project documentation, technical modifications, and as-built information are properly collected, maintained, archived, and readily available to support operational excellence, compliance, and inspection readiness.

This position plays a critical role in strengthening engineering governance, improving documentation quality, supporting regulatory compliance, and ensuring the long-term maintainability of the facility.

Key Responsibilities

• Establish, organize, and maintain a centralized repository for engineering and as-built documentation.
• Identify, collect, consolidate, and structure existing engineering records, historical project files, technical modifications, and facility documentation.
• Ensure the integrity, accuracy, accessibility, and traceability of engineering documentation throughout its lifecycle.
• Maintain historical engineering records for facilities, utilities, equipment, infrastructure, and site systems.
• Ensure as-built documentation is updated, archived, and controlled in accordance with site procedures and project requirements.
• Maintain the engineering department training plan and training documentation.

Documentation Governance & Engineering Way of Working

• Develop and implement a Way of Working (WoW) for good engineering practices, training and as-built document management.
• Create standards, processes, training and best practices for good engineering practices, qualification, document creation, project handover, and archiving.
• Support engineering teams and project managers in complying with documentation requirements throughout project execution.
• Ensure proper documentation handover, review, and filing at project closeout.
• Drive continuous improvements in engineering documentation processes and governance.

Compliance & Inspection Readiness

• Support Good Engineering Practices (GEP) and GxP documentation compliance activities.
• Ensure engineering documentation is maintained in a state of inspection readiness.
• Assist with audits, inspections, and compliance assessments by providing accurate and traceable documentation.
• Support the management of documentation-related observations, corrective actions, and compliance initiatives.
• Promote a quality and compliance mindset across engineering and project teams.

Qualifications & Experience

Education

• Minimum Bachelor’s degree in engineering, Information management, Quality Management, Life Sciences, or a related discipline.

Experience

• Minimum 3 years of experience in GMP documentation, project coordination, compliance, quality systems, or a related field.
• Experience working in a pharmaceutical, biotechnology, manufacturing, or other regulated environment is highly desirable.
• Experience with engineering projects, validation, document control systems, and technical archives is a strong asset.

Technical Skills

• 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 document management systems (eDMS), SharePoint, and Microsoft Office applications.
• Excellent capability to manage large volumes of technical information and documentation.
• Fluent in English & Dutch or French
• Strong organizational and planning skills.
• Exceptional 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 with the ability to work across multiple functions and departments.
• Continuous improvement orientation and commitment to operational excellence.

Why Join Us?

This is a unique 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, inspection readiness, and the long-term sustainability of our facilities while working closely with engineering, project management, quality, and compliance teams.

Our Company

Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at 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 chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

We offer

• Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
• In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
• We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
• At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

Furthermore, we value mutual respect and diversity is our strength.

At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!