Qualification & Validation Engineer – Packaging & Combination Products
Il y a 20 heures
Jette, Brussels, Belgique
Nalys
Temps plein
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Qualification & Validation Engineer – Packaging & Combination Products
📍 Walloon Brabant, Belgium (Hybrid)
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 & Validation Engineer, you will join the Q&V team of a leading biopharmaceutical manufacturing site. The team supports production, assembly and packaging equipment. Your first priority will be a Periodic Qualification Review project with a year-end deadline. After that, you will contribute to upcoming projects focused on packaging activities. This role combines documentation with hands-on work on the shop floor. You will work on equipment used to assemble and package combination products, in a GMP environment where reliability and compliance are essential. We’re looking for an autonomous and proactive Q&V engineer with solid experience in packaging, medical devices and sterilization. You should be ready to take ownership of your activities from day one. The Role & Responsibilities Working within the Qualification & Validation team and alongside operational and project teams, your responsibilities will include:
• Reviewing the qualification status of equipment as part of a Periodic Qualification Review
• Preparing and executing qualification and validation protocols on production and packaging equipment
• Supporting the assembly and packaging of combination products (drug-device)
• Investigating deviations and technical issues, and proposing appropriate solutions
• Contributing to packaging-related projects from preparation to follow-up
• Maintaining accurate, up-to-date qualification documentation
• Coordinating with stakeholders to ensure activities are delivered on time. Skills & Qualifications
• You have at least 3 years of experience in Qualification & Validation within a manufacturing environment
• You have hands-on experience qualifying production and packaging equipment
• You have worked on assembly and packaging equipment for combination products
• Your experience in packaging, medical devices and/or sterilization is a key advantage
• You work independently, solve problems effectively and bring a positive, team-oriented attitude
• You are fluent in French and can read and write technical documentation in English
• Experience in Computerized System Validation (CSV) is a strong asset
• Please note: profiles limited to laboratory equipment qualification are not a fit for this role. The Recruitment Process By applying for the “Qualification & Validation Engineer” 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 on of our Technical Referents
• The last interview will be with our Business Unit Director, Jimmy Rousseaux. If you enjoy getting hands-on with equipment and want to help bring combination products safely to patients, please apply directly here or contact our TA Specialist, Olivia Braszko : obraszko@nalys-group.com
Job Description
As a Qualification & Validation Engineer, you will join the Q&V team of a leading biopharmaceutical manufacturing site. The team supports production, assembly and packaging equipment. Your first priority will be a Periodic Qualification Review project with a year-end deadline. After that, you will contribute to upcoming projects focused on packaging activities. This role combines documentation with hands-on work on the shop floor. You will work on equipment used to assemble and package combination products, in a GMP environment where reliability and compliance are essential. We’re looking for an autonomous and proactive Q&V engineer with solid experience in packaging, medical devices and sterilization. You should be ready to take ownership of your activities from day one. The Role & Responsibilities Working within the Qualification & Validation team and alongside operational and project teams, your responsibilities will include:
• Reviewing the qualification status of equipment as part of a Periodic Qualification Review
• Preparing and executing qualification and validation protocols on production and packaging equipment
• Supporting the assembly and packaging of combination products (drug-device)
• Investigating deviations and technical issues, and proposing appropriate solutions
• Contributing to packaging-related projects from preparation to follow-up
• Maintaining accurate, up-to-date qualification documentation
• Coordinating with stakeholders to ensure activities are delivered on time. Skills & Qualifications
• You have at least 3 years of experience in Qualification & Validation within a manufacturing environment
• You have hands-on experience qualifying production and packaging equipment
• You have worked on assembly and packaging equipment for combination products
• Your experience in packaging, medical devices and/or sterilization is a key advantage
• You work independently, solve problems effectively and bring a positive, team-oriented attitude
• You are fluent in French and can read and write technical documentation in English
• Experience in Computerized System Validation (CSV) is a strong asset
• Please note: profiles limited to laboratory equipment qualification are not a fit for this role. The Recruitment Process By applying for the “Qualification & Validation Engineer” 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 on of our Technical Referents
• The last interview will be with our Business Unit Director, Jimmy Rousseaux. If you enjoy getting hands-on with equipment and want to help bring combination products safely to patients, please apply directly here or contact our TA Specialist, Olivia Braszko : obraszko@nalys-group.com