Computer System Validation Engineer (CSV Engineer) | Global Life Sciences / GMP Manufacturing Environment
Company Description
A global leader in life sciences and biomanufacturing, this organization operates across five continents, driving innovation and excellence in health solutions. The Bornem site plays a key role in supporting European operations — combining scientific advancement with strong operational and financial performance. The company empowers its people to take ownership of their ideas and careers, fostering an environment where innovation drives meaningful global impact.
Job Description
As a Computer System Validation (CSV) Engineer, you will be responsible for ensuring all computerized systems used in manufacturing, laboratory, and business operations comply with GxP regulations and internal CSV procedures. You will manage the full validation lifecycle — from user requirements and risk assessments through qualification testing and periodic reviews — ensuring data integrity, patient safety, and product quality.
This is a hands-on, on-site position requiring collaboration with cross-functional teams, system vendors, and process owners to maintain validated systems and continuously improve compliance and operational reliability.
Key Responsibilities
Validation Lifecycle Management
- Manage the full lifecycle validation of computerized systems (manufacturing, laboratory, and business systems).
- Ensure all systems are designed, validated, operated, and retired in accordance with GxP regulations and company procedures.
- Compile and maintain complete CSV documentation with full traceability throughout system lifecycles.
Documentation & Testing
- Develop and execute validation deliverables, including:
- User Requirements Specifications (URS)
- Risk Assessments (Functional, Data Integrity, Audit Trail)
- Validation Plans and Traceability Matrices
- Test Protocols (IQ, OQ, PQ) and associated reports
- Validation Summary Reports
- Execute and document IQ/OQ protocols; participate in PQ activities.
- Conduct periodic reviews to maintain validated state throughout system operation.
Compliance & System Administration
- Draft and maintain system administration work instructions (user management, data management, backup/restore, disaster recovery).
- Define and document computerized system audit trail logbooks, including event review procedures.
- Support process owners in identifying, implementing, and upgrading systems to improve compliance and mitigate risks to product quality and data integrity.
Cross-Functional Collaboration
- Work closely with system vendors to leverage validation documentation and technical support.
- Support training activities by collaborating with system administrators and the Training & Development team to ensure users operate systems in compliance with procedures and regulations.
Essential Requirements
- Degree or post-graduate education in a life sciences discipline, or equivalent relevant experience.
- Proven experience in Computer System Validation within a GxP-regulated or pharmaceutical/biotech environment.
- Strong understanding of GAMP 5, Annex 11, and FDA 21 CFR Part 11 principles.
- Excellent documentation, analytical, and communication skills.
- Proficiency in French and English (spoken and written).
- Ability to work on-site in Bornem, Belgium.
Desirable Qualifications
- Experience validating manufacturing or laboratory systems (LIMS, MES, ERP, or similar).
- Knowledge of Data Integrity principles and risk management methodologies.
- Familiarity with computerized system audits and vendor qualification processes.
- Team-oriented mindset with the ability to work independently on multiple concurrent projects.
Additional Insights
Location: Bornem, Belgium
Department: Quality / Validation / Compliance
Start Date: ASAP
Interested? Please send your CV to Miguel Gomes at m.gomes@panda-int.com or reach out directly at +31 20 20 44 502.