Job description
Mission Description
We are seeking a skilled and motivated Validation Engineer to join our team, supporting the validation of computerized systems within a cGMP-regulated pharmaceutical environment. The ideal candidate will ensure that all systems remain in a validated state throughout their lifecycle, in compliance with regulatory requirements (FDA, EU GMP, 21 CFR Part 11) and internal standards.
This role is hands-on and project-driven, with a focus on delivering robust validation documentation and execution for critical systems used in manufacturing, laboratory, and quality operations.
Key Accountabilities
* Develop, implement, and execute User Requirement Specifications (URS), System Impact Assessment (SIA), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Revalidation (RV), and Transfer Management (TM).
* Author, review, and approve validation documentation (protocols and reports) for computerized systems in accordance with cGMP, cGLP, and company procedures.
* Execute validation activities independently, ensuring compliance with Sanofi standards and global regulatory expectations.
* Interpret industry standards and regulations to apply them contextually to specific systems and projects.
* Maintain the validated state of computerized systems through change control assessment, periodic reviews, and impact analysis.
* Troubleshoot and investigate validation-related deviations, anomalies, or system issues; contribute to root cause analysis and CAPA.
* Collaborate with cross-functional teams (IT, Engineering, Quality, Operations) to deliver projects on time and in compliance.
* Stay up to date with evolving regulatory trends (e.g., FDA, EMA) and industry best practices in computer systems validation (CSV) and data integrity.
* Provide technical input on regulatory requirements during audits, inspections, and system upgrades.
Skills & Experience Required
* Minimum 3 years of experience in a pharmaceutical or life sciences environment within a GMP-regulated setting.
* Proven experience in Computerized Systems Validation (CSV) including software packages, LIMS, MES, SCADA, and/or DCS platforms.
* Solid understanding of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity principles.
* Demonstrated ability to work independently, manage workload, and deliver projects on schedule.
* Strong written and verbal communication skills; able to collaborate effectively across departments.
* Proficient in English; knowledge of Dutch is required.
* Experience with Emerson DeltaV DCS is a strong advantage.
* Ability to interpret technical and regulatory requirements and apply them to real-world validation scenarios.
* Familiarity with change control, deviation management, and quality systems.
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.