Senior C&Q Engineer for Pharmaceutical Filling Lines

Nalys; Wallonië; Sur place; EUR 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Continuous learning

Career development

Autonomy

Résumé du poste

Nalys is seeking a Senior Commissioning & Qualification Engineer to support a pharmaceutical manufacturing site in Belgium, driving commissioning and qualification of complete filling lines. You will work across the equipment lifecycle, coordinating FAT/SAT and collaborating with suppliers on QA and GMP aspects on site.

The role involves hands-on field work, two extended FAT assignments abroad, and close coordination with Engineering, Production, Quality, and suppliers to ensure traceability and

Qualifications

• Engineering degree or equivalent technical background.
• Experience as a C&Q Engineer, able to work autonomously.
• Solid hands-on C&Q experience within pharmaceutical / GMP environments.
• Experience with filling machines or complete filling lines strongly preferred.
• Strong background in FAT/SAT and equipment qualification.
• Able to understand and challenge equipment suppliers from a technical and GMP/C&Q standpoint.
• Pragmatic, field-oriented profile — not purely documentation-focused.
• Fluent in both English and French.

Responsabilités

• Prepare, coordinate and execute Commissioning & Qualification activities for filling equipment and associated systems
• Review equipment design and supplier documentation from a technical, C&Q and GMP perspective
• Prepare and/or review qualification protocols and documentation
• Participate in and challenge FAT execution at the equipment manufacturers' facilities abroad
• Manage FAT observations, punch lists, deviations and corrective actions
• Support installation, commissioning and start-up of the equipment on site
• Execute and/or coordinate SAT, IQ and OQ activities
• Ensure traceability between requirements, testing and qualification documentation
• Collaborate closely with Engineering, Production, Quality and equipment suppliers
• Troubleshoot technical and qualification issues and drive them to resolution.

Connaissances

Autonomous work

C&Q experience

GMP compliance

FAT/SAT experience

Pharma equipment qualification

English fluency

French fluency

Formation

Engineering degree or equivalent

Description du poste

Nalys is seeking a Senior Commissioning & Qualification Engineer to support a pharmaceutical manufacturing site in Belgium, driving commissioning and qualification of complete filling lines. You will work across the equipment lifecycle, coordinating FAT/SAT and collaborating with suppliers on QA and GMP aspects on site.

The role involves hands-on field work, two extended FAT assignments abroad, and close coordination with Engineering, Production, Quality, and suppliers to ensure traceability and