Qualification Engineer

Nalys; Brussel Hoofdstad; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

V-model

FMEA

GMP

Equipment qualification

French & English

Autonomous

Descripción del empleo

Qualification Specialist – Equipment & Clean Utilities

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As a Qualification Specialist, you will join a large biopharmaceutical production site.

You will take ownership of a variety of qualification projects covering cold storage units, laboratory equipment, clean utilities and classified-area facilities.

Your mission will be to ensure that every system is designed, installed and operating in full compliance with GMP expectations.

This role covers the complete qualification lifecycle, from risk assessment and user requirements through to final reports. You will work hand in hand with engineering, quality and operations teams.

We’re looking for an experienced and autonomous qualification professional. You should be comfortable both behind the desk and on the shop floor, and take pride in delivering reliable work on time.

The Role & Responsibilities

Working within the qualification team and in close collaboration with engineering, quality and end-user stakeholders, your responsibilities will include:

• Drafting, reviewing, executing and approving technical documents such as risk assessments, URS, DQ and FDS
• Preparing, executing and approving qualification protocols and reports (FAT/SAT, IQ, OQ, PQ)
• Qualifying equipment and systems such as freezers and refrigerators, laboratory instruments, clean utilities (water and gases) and cleanroom facilities
• Handling deviations, CAPAs and change controls related to qualification activities
• Writing and maintaining SOPs and qualification-related documentation
• Leading root cause investigations and risk analyses
• Driving continuous improvement in line with new technologies, regulatory changes and site needs
• Supporting customer audits and regulatory inspections.

Skills & Qualifications

• You have minimum 4 years of proven experience in equipment qualification and validation
• You master the V-model approach
• You have hands-on experience writing, executing and reviewing qualification protocols, reports and technical documents
• You are experienced in risk analysis (e.g., FMEA) and root cause investigation tools
• You have worked in a GMP environment and know the relevant regulations, such as EU GMP and 21 CFR
• Experience with clean utilities (WFI, purified water, clean steam) is a strong asset
• You are proactive, autonomous and reliable, with a strong sense of ownership and integrity
• You are customer-oriented and enjoy working as part of a team
• You are fluent in both French and English.

The Recruitment Process

By applying for the “Qualification Specialist” position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening
• You will have a second interview with one of our Technical Referents
• The last interview will be with our Business Unit Director, Alexandre Ivankovich.