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Validation Engineer Medior

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Amaris Consulting

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Location:
Belgium , Wavre

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Category:
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Salary:

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Job Description:

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.

Job Responsibility:

  • 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
  • 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)
  • 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
  • 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
  • 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

Requirements:

  • 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
  • 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
  • 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)

Nice to have:

  • 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)
What we offer:
  • 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

Additional Information:

Job Posted:
March 25, 2026

Employment Type:
Fulltime
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