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Validation Specialist - GMP Operations - Louvain-la-Neuve & Gosselies

Ottignies-Louvain-La-Neuve, Belgium

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Why this role matters


As a Validation Specialist, you will join our GMP Operations team and play a key role in the development, and the execution of qualification and validation activities for bacteriophage production. 

This position is critical to ensuring robust, safe, and compliant production of phage batches in a regulated environment.

What your days could look like


Qualification & Validation Execution                                      

  • Coordinate and execute qualification and validation activities according to the Validation Master Plan.                                                                                                                
  • Write and execute qualification and validation protocols and reports; perform and/or review equipment and system tests and analyze the results.                        
  • Review subcontractor protocols and reports.                                                                                                                                                                                                                                          
  • Design and execute a periodic revalidation plan and process development validation routines.                                                                                   

Collaboration, Documentation & Quality Compliance                                          

  • Work closely with Engineering, Operations, Process Development, Maintenance/Calibration and Quality teams; ensure effective handover of information and ongoing activities with GMP Operations.        
  • Train operational staff on validation protocols, procedures and best practices.                                                                                 
  • Maintain accurate and traceable records of all commissioning, qualification and validation activities in a GMP-compliant manner, in line with ALCOA+ data integrity principles.                                 
  • Contribute to deviation management, Change Control, CAPA and risk analyses related to qualification and validation activities. 
  • Participate in internal and external audits and inspections; prepare evidence, execute actions and sustain compliance.                 

GMP Set-up & Validation Strategy                        

  • Participate in the deployment of the new GMP production, defining robust qualification and validation strategies aligned with EU GMP, ICH guidelines and Belgian regulatory requirements.                      
  • Contribute to the qualification of cleanrooms, manufacturing equipment, utilities and systems with external suppliers.                      
  • Create or contribute to validation documentation, from Master Plans to validation protocols, and ensure delivery in compliance with quality requirements and project timelines.
  • Design and execute process validation activities for GMP processes (expl: cleaning, decontamination, gowning, CCIT, aseptic process validation, transport and cold chain).
  • Conduct risk assessments using ICH principles (expl: cross-contamination, filter integrity, extractables & leachables).
  • Integrate validation activities within the Quality Management System (QMS) and support regulatory submissions, inspections and audits.    

What you bring to the table

  • Master’s degree in Pharmaceutical Technology or Engineering, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
  • 3-7 years of validation experience in pharmaceutical manufacturing.
  • Experience with sterile manufacturing and biologics is highly preferred.
  • Knowledge of Belgian pharmaceutical regulations and EU GMP.
  • Strong understanding of validation lifecycle approaches and risk‑based validation methodologies (ICH related).
  • Knowledge or experience in equipment qualification processes and/or process validation.
  • Knowledge of plant systems and related equipment and utilities (HVAC, cleanrooms, incubators, refrigerators) is a plus.
  • Working knowledge of GMP standards and experience with GMP Quality Systems (deviations, CAPA, Change Control).
  • Ability to comply with safety rules at all times.
  • Strong organizational, analytical, and problem‑solving skills.
  • Excellent communication and cross‑functional collaboration abilities.
  • Ability to work independently in fast‑paced start‑up or scale‑up environments with initiative and a proactive, solution‑oriented mindset.
  • Excellent written and verbal communication skills in English and French.

What you’ll love about working here

Inspiring Mission

Join a high-potential biotech fighting antimicrobial resistance with cutting-edge science.

Strategic Impact

Lead global efforts to bring next-gen solutions to market and transform the fight against antibiotic resistance.

Growth Opportunities

Develop your skills and grow professionally in a dynamic environment.

Empowered Leadership 

Drive change within a passionate team that supports and challenges each other to excel.  


Attractive Compensation

Enjoy a competitive package aligned with your role and experience.

Work-Life Flexibility

Benefit from hybrid work and flexible hours tailored to your lifestyle.

Innovation Culture

 Be part of a team that values collaboration, creativity, and mission-first thinking.

Fun & Team Spirit

Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.

Ready to make an impact?

We’d love to hear your story. Apply today!

Apply Now!