Project Documentation & Validation Coordinator

Pauwels Consulting; Vlaams-Brabant; Sur place; EUR 60 000 - 75 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a Project Documentation & Validation Coordinator to join its engineering team in Belgium. You will manage project documentation and drive validation activities to ensure compliance across disciplines.

You will develop and execute IQ/OQ/PQ protocols, support CSV and process validation for manufacturing systems, and coordinate deliverables with engineering, QA, and production. Fluency in English is required; Dutch is a plus. 3+ years in life sciences validation is expected.

Qualifications

• Master’s or Bachelor’s degree in Industrial Engineering, Electromechanics, Biochemistry, or a related field.
• 3+ years of relevant experience in a validation or documentation role within the life sciences sector.
• Knowledge of GMP compliance, risk management, and maintaining document traceability.
• You bring expertise in validation disciplines including process validation, equipment qualification, and IQ/OQ/PQ.
• Knowledge of CSV, automated manufacturing systems, and data integrity requirements.
• Proficiency in Excel, SharePoint, and Word.
• Fluency in English.

Responsabilités

• Collect, organize, and maintain project documentation across validation, quality, and engineering disciplines.
• Execute validation activities for equipment and systems in accordance with approved procedures and project requirements.
• Support the development and execution of IQ, OQ, and PQ protocols.
• Assist with CSV and process validation activities for manufacturing systems and automated equipment.
• Coordinate validation-related deliverables with engineering, QA, and production stakeholders.
• Identify and document deviations, issues, and observations during qualification activities.

Connaissances

Validation expertise

Documentation

Quality systems

GMP awareness

Data integrity

Risk management

English proficiency

Dutch (nice to have)

Formation

Master’s or Bachelor’s degree in Industrial Engineering, Electromechanics, Biochemistry, or related field

Outils

Excel

SharePoint

Word

Description du poste

Our client is seeking a Project Documentation & Validation Coordinator to join their engineering team. The role involves managing project documentation and executing validation activities to ensure compliance across various engineering disciplines.

• Collect, organize, and maintain project documentation across validation, quality, and engineering disciplines.
• Execute validation activities for equipment and systems in accordance with approved procedures and project requirements.
• Support the development and execution of IQ, OQ, and PQ protocols.
• Assist with CSV and process validation activities for manufacturing systems and automated equipment.
• Coordinate validation-related deliverables with engineering, QA, and production stakeholders.
• Identify and document deviations, issues, and observations during qualification activities.

• You possess a Master’s or Bachelor’s degree in Industrial Engineering, Electromechanics, Biochemistry, or a related field.
• You have 3+ years of relevant experience in a validation or documentation role within the life sciences sector.
• You bring expertise in validation disciplines including process validation, equipment qualification, and IQ/OQ/PQ.
• You have knowledge of CSV, automated manufacturing systems, and data integrity requirements.
• You're familiar with GMP compliance, risk management, and maintaining document traceability.
• You have experience using digital tools such as Excel, SharePoint, and Word.
• You are proficient in English.

Nice to Haves

• Active knowledge of Dutch.