Process Validation Engineer

Process Validation Engineer – Biologics Manufacturing

📍 Hainaut, Belgium

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 Process Validation Engineer , you will join the Manufacturing Science department of a large biopharmaceutical production site.

Your mission will be to act as the validation representative on process validation projects of all sizes. You will make sure manufacturing processes are robust, compliant and consistently in a validated state.

This role sits at the heart of the process validation lifecycle, from development through regulatory submission to routine production. You will work closely with manufacturing, quality and regulatory teams.

We’re looking for a curious and structured validation professional with a solid understanding of biologics manufacturing. You should enjoy combining technical analysis with hands-on coordination on the shop floor.

The Role & Responsibilities

Working within the Manufacturing Science team and in close collaboration with production, quality and regulatory stakeholders, your responsibilities will include:

• Defining, preparing and implementing process validation activities for small, mid-size and large projects
• Drafting validation plans that set out the methodology and approach
• Participating in risk assessments and ensuring requirements traceability throughout the validation file
• Coordinating validation activities on the ground with all involved departments to meet project timelines
• Analyzing, interpreting and reporting test results
• Maintaining the validated status of processes in line with local and global PV strategies
• Contributing to continuous improvement and process robustness initiatives
• Supporting GMP compliance, regulatory submissions and audit defenses.

Skills & Qualifications

• You hold a Bachelor’s or Master’s degree in Engineering, Chemistry, Life Sciences or a related field, or have equivalent experience
• You have at least 2 years of experience in validation, quality systems or a similar role
• You have a good knowledge of process validation methodologies and risk assessment tools
• You understand manufacturing processes in biologics, such as protein purification and filling
• You are familiar with cGMP, GDP and quality systems
• You bring data analytics, problem-solving and project management skills
• You communicate clearly in English, both verbally and in writing
• You are customer-oriented, flexible and open to out-of-the-box thinking.

The Recruitment Process

By applying for the “ Process Validation Engineer ” position, you will go through the following steps in our recruitment process:

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

If you’re passionate about process robustness and want to help deliver life-changing biologics to patients, please apply directly here or contact our TA Specialist : [email protected]