Qualification & Validation Engineer

Contenido de trabajo

Qualification & Validation Engineer

????Location: Louvain-la-Neuve, Belgium (Hybrid)

About Nalys

Nalys is a fast-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 a dynamic team within a leading life sciences environment. You will be responsible for planning, executing, and documenting qualification and validation activities for equipment, utilities, and processes in compliance with GMP and regulatory standards. This role requires strong technical expertise, attention to detail, and the ability to work cross-functionally in a fast-paced setting.

The Role & Responsibilities

Reporting to the project leadership team, your responsibilities will include:

• Developing and executing qualification and validation protocols (IQ/OQ/PQ) for equipment, utilities, and systems
• Performing risk assessments and ensuring compliance with GMP and regulatory requirements
• Managing validation projects from planning to final reporting, including change control
• Collaborating with engineering, production, and quality teams to ensure timely execution of validation activities
• Troubleshooting and resolving technical issues related to equipment qualification and process validation
• Maintaining accurate documentation and supporting audits and inspections
• Driving continuous improvement initiatives in validation processes and methodologies.

Skills & Qualifications

• You hold a Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field
• You have at least a minimum of 3 years of experience to 10 years in qualification and validation within a GMP-regulated environment (pharmaceutical or biotech)
• You have a first expoerience in validation principles, regulatory guidelines (EU GMP, FDA), and risk-based approaches
• And experience with equipment qualification, process validation, and computerized system validation
• You work as a good organizer and project manager
• Strong communication skills and ability to work collaboratively across departments
• You are fluent in both English and French.

Your Team

You will be part of a multidisciplinary team focused on ensuring product quality and regulatory compliance. The team collaborates closely with engineering, production, and quality assurance to deliver robust and reliable processes aligned with broader organizational goals.

Recruitment Process

By applying for the Q&V Engineerposition, you will go through the following steps in our recruitment process:

“If you are passionate about quality, compliance, and technical excellence, and want to contribute to a forward-thinking team, we’d love to hear from you!”