Validation Engineer Medior [F/M/X]

Job description

Position Overview

We are seeking a highly skilled Validation Engineer to join our pharmaceutical manufacturing team in Belgium. This role is critical to ensuring our manufacturing processes, equipment, and systems meet all regulatory requirements and quality standards. The ideal candidate will have extensive experience in validation activities within the pharmaceutical industry, with deep knowledge of EU GMP, ICH guidelines, and Belgian regulatory requirements.

 

Key Responsibilities

Process Validation

• Lead and execute process validation activities for new and existing pharmaceutical products

• Develop and implement validation master plans and validation protocols (IQ/OQ/PQ)

• Ensure validation activities align with ICH Q8/Q9/Q10 guidelines 

• Conduct risk assessments using ICH Q9 principles for validation strategies 

 

Equipment & System Qualification

• Perform qualification activities for manufacturing equipment, utilities, and systems

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

• Manage re-qualification activities per regulatory requirements 

• Coordinate with suppliers for Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)

 

Regulatory Compliance

• Ensure all validation activities comply with EU GMP Annex 15 and Belgian regulatory requirements

• Prepare and review validation documentation for regulatory submissions

• Support regulatory inspections and audits (FDA, EMA, FAGG/AFMPS)

• Maintain current knowledge of EU pharmaceutical regulations and ICH guidelines

 

Quality Systems

• Integrate validation activities within the Quality Management System (QMS)

• Ensure proper change control and CAPA processes for validation-related issues 

• Maintain data integrity standards per ALCOA+ principles

• Support continuous process verification initiatives

 

Cross-functional Collaboration

• Work closely with Manufacturing, QA, QC, Engineering, and Regulatory Affairs

• Provide technical guidance on validation requirements for process improvements and technology transfers

• Train operational staff on validation protocols and procedures

 

Required Qualifications

Education & Experience

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field

• 5+ years of validation experience in pharmaceutical manufacturing

• Experience with sterile manufacturing and biologics is highly preferred

• Knowledge of Belgian pharmaceutical regulations and EU GMP

 

Technical Skills

• Strong understanding of validation lifecycle approaches

• Proficiency in risk-based validation methodologies (ICH Q9)

• Experience with continuous manufacturing validation (ICH Q13

• Knowledge of data integrity requirements in regulated environments

 

Regulatory Knowledge

• EU GMP (especially Annex 15 - Qualification and Validation)

• ICH Guidelines (Q8, Q9, Q10, Q11, Q12, Q13)

• FDA 21 CFR Part 211 and EU Directive 2001/83/EC

• Belgian pharmaceutical legislation (FAGG/AFMPS requirements)

 

Preferred Qualifications

• Master's degree in Pharmaceutical Technology or Engineering

• Validation certifications (e.g., ISPE CPIP, PDA)

• Experience with biologics, ATMPs, or sterile injectables

• Knowledge of digital validation tools and electronic systems

• Dutch/French language skills (working in Belgium)

 

Why joining us?

 

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

 

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:   

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you! 

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.   

As you know, every person is different and so is every role in a company.  That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. 
We look forward to meeting you!