Job description
Role Overview
Lead computer system validation for automated/computerized systems ensuring GMP compliance across vaccine manufacturing operations.
Key Responsibilities
* Validation Leadership: Author/review/approve validation plans, summary reports, and periodic review reports
* Design Oversight: Review design documentation (TCD, ERES, URS, DQ) and qualification protocols/reports (IQ/OQ/PQ)
* CSV Governance: Manage CSV documentation inventory and review SOPs/templates
* Quality Assurance: Execute qualification/validation per established methodology; manage CAPA, deviations, change control
* Audit Support: Represent validation function during internal/external audits
* Cross-functional Collaboration: Lead multidisciplinary teams through validation lifecycle
Required Qualifications
* Education: Master's in Sciences/Biological Engineering (Pharmacist, Bio-Engineer, or equivalent)
* Experience: 7-10 years in computer system validation within pharmaceutical manufacturing
* Technical Expertise:
o cGMP regulations (GAMP, Eudralex Vol 4 Annex 11, 21 CFR Part 11)
o Validation frameworks (ICH, ASTM E2500, lifecycle approach)
o SAP and MS Office proficiency
* Languages: Fluent in both French and English is mandatory
Core Competencies
* Analytical: Investigative mindset with strong questioning skills
* Leadership: Ability to influence cross-functional teams
* Quality Focus: Rigorous, systematic approach to validation
* Communication: Clear technical writing and stakeholder management
* Autonomy: Self-directed with critical thinking capabilities
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.