Engineering Documentation & Compliance Specialist

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

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.