GMP Qualification Lead – Equipment & Clean Utilities

Nalys; Brussel Hoofdstad; On-site; EUR 65,000 - 90,000; Full time

Job summary

Nalys is seeking a Qualification Specialist to join a large biopharmaceutical production site in Belgium. You will own qualification projects for equipment, cold storage, and clean utilities, ensuring full GMP compliance from risk assessment to final reports.

Collaboration with engineering, quality and operations is essential, with hands-on shop-floor involvement and strong ownership expectations. The role requires at least 4 years in equipment qualification/validation, experience with the

Qualifications

• 4+ years of proven experience in equipment qualification and validation.
• Experience with the V-model approach.
• Experience writing, executing and reviewing qualification protocols and reports.
• Knowledge of risk analysis (FMEA) and root cause investigations.
• GMP environment knowledge incl EU GMP and 21 CFR.
• Experience with clean utilities (WFI, purified water, clean steam) is a strong asset.
• Fluent in French and English.

Responsibilities

• Draft, review, execute and approve technical documents such as risk assessments, URS, DQ and FDS.
• Prepare, execute and approve qualification protocols and reports (FAT/SAT, IQ, OQ, PQ).
• Qualify equipment and systems such as freezers and refrigerators, lab instruments, clean utilities and cleanroom facilities.
• Handle deviations, CAPAs and change controls related to qualification activities.
• Write and maintain SOPs and qualification-related documentation.
• Lead root cause investigations and risk analyses.
• Drive continuous improvement in line with new technologies and regulatory changes.
• Support customer audits and regulatory inspections.

Skills

V-model

FMEA

GMP

Equipment qualification

French & English

Autonomous

Job description

Nalys is seeking a Qualification Specialist to join a large biopharmaceutical production site in Belgium. You will own qualification projects for equipment, cold storage, and clean utilities, ensuring full GMP compliance from risk assessment to final reports.

Collaboration with engineering, quality and operations is essential, with hands-on shop-floor involvement and strong ownership expectations. The role requires at least 4 years in equipment qualification/validation, experience with the