Validation Engineer

Nalys; Waals-Brabant; On-site; EUR 60,000 - 85,000; Full time

Job summary

Nalys is seeking a Validation Engineer to join its Manufacturing Science & Technology (MSAT) organization for a leading global biopharma client in Belgium. You will drive validation projects from kick-off to completion, from equipment qualification to process validation, in a GMP-regulated environment.

You will collaborate with production, quality, QC and engineering stakeholders, ensuring timely delivery and robust change control, IQ/OQ/PQ execution, and risk assessments for validated

Qualifications

• Minimum 3 years of experience in a pharmaceutical environment, within quality and validation.
• IQ/OQ/PQ validation experience and related documentation.
• Strong knowledge of GMP requirements related to validation activities.

Responsibilities

• Managing validation projects: presenting projects and escalating status in internal governance, organizing kick-offs, planning and follow-up, and managing stakeholders
• Coordinating the change control process for short-, mid- and long-term projects
• Assessing the validation impact of changes through the electronic change control system and owning the related tasks
• Writing and reviewing IQ/OQ protocols and reports to ensure equipment qualification
• Supporting the team in the creation of risk analyses
• Writing and reviewing equivalence certificates
• Designing the validation strategy and writing PQ protocols in line with company standards and procedures
• Ensuring PQ readiness and coordinating validation activities
• Acting as the main point of contact with Quality Control.

Skills

Validation experience

Project management

GMP knowledge

French & English fluency

Teamwork in matrix environment

Proactive & organized

Education

Bachelor's degree in Biotechnology/ Chemistry/ Pharmacy or related

Job description

Validation Engineer - Pharmaceutical Manufacturing

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 Validation Engineer, you will join the Manufacturing Science & Technology (MSAT) organization of a leading global bio pharmaceutical company.

You will be responsible for validation and change control activities for projects within a vaccine manufacturing unit.

This role combines project management and hands-on technical expertise.

You will drive validation projects from kick-off to completion, from qualification of equipment to process validation, in a strictly GMP-regulated environment.

We’re looking for someone with validation experience, strong organizational skills, and a proactive mindset to ensure every project is delivered compliantly and on time.

The Role & Responsibilities

Working closely with production, quality, QC and engineering stakeholders, your responsibilities will include:

• Managing validation projects: presenting projects and escalating status in internal governance, organizing kick-offs, planning and follow-up, and managing stakeholders
• Coordinating the change control process for short-, mid- and long-term projects
• Assessing the validation impact of changes through the electronic change control system and owning the related tasks
• Writing and reviewing IQ/OQ protocols and reports to ensure equipment qualification
• Supporting the team in the creation of risk analyses
• Writing and reviewing equivalence certificates
• Designing the validation strategy and writing PQ protocols in line with company standards and procedures
• Ensuring PQ readiness and coordinating validation activities
• Acting as the main point of contact with Quality Control.

Skills & Qualifications

• You hold a university degree in Biotechnology, Agronomy, Chemistry, Pharmacy or a related field
• You have minimum 3 years experience in a pharmaceutical environment, within quality and validation
• You have proven experience in change control and validation (IQ/OQ/PQ)
• You have good knowledge of GMP requirements related to validation activities
• You have experience in project management and are problem-solving and achievement oriented
• You communicate fluently in French and English, both orally and in writing
• You are a team player who thrives in a matrix organization
• You are proactive, well organized, and able to take decisions and manage multiple deliverables under pressure
• Knowledge of cold rooms, thawing baths, isolators, incubators, HVAC, E&L, MBHT or CCIT is a strong asset.

The Recruitment Process

By applying for the “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 one of our Technical Experts
• The last interview will be with our Business Unit Director, Jimmy Rousseaux.