Job description
Mission / Role Overview
As a Computer Systems Validation (CSV) Engineer, you will support the validation of cGMP‑critical computerized systems and software packages within a pharmaceutical/GMP environment. You will contribute to the full validation lifecycle (URS to PQ), ensuring systems remain in a validated state and compliant with cGMP, cGLP, FDA and EU regulations, as well as internal procedures.
Key Responsibilities
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o URS, SIA, DQ, IQ, OQ, PQ, RV and TM
o Validation studies for cGMP‑critical computerized systems to demonstrate compliance with cGMP, user and regulatory requirements
Develop, implement and execute validation activities and documentation, including:
* Prepare and maintain validation documentation (protocols, reports, test scripts) and support/perform protocol execution for computerized systems.
* Own validation documentation through review, approval and implementation.
* Perform validation of systems where industry precedence exists but standards must be interpreted and adapted to the specific case, in line with cGMP, cGLP and internal procedures.
* Ensure the validated status of computerized systems is maintained and compliant with cGMP at all times.
* Contribute to project execution in accordance with all applicable company and cGMP regulatory standards.
* Stay current on emerging validation regulations, guidelines and testing practices to meet or exceed cGMP requirements.
* Provide technical input on current US FDA and EU validation requirements.
* Participate in change assessments to determine impact on validated status and validation documentation.
* Investigate and troubleshoot validation issues and deviations, proposing and implementing corrective actions.
Profile & Requirements
Experience
* 1–3 years of experience in Computer Systems Validation or related QA/Validation roles.
* Minimum 3 years’ experience in a pharmaceutical sector and GMP environment (project, internship or combined roles can be considered if strongly relevant).
* Project experience with validation of software packages and computerized systems.
Technical Skills
* Solid understanding of Computer Systems Validation principles and lifecycle.
* Good knowledge of cGMP, cGLP and relevant quality/compliance regulations (e.g. 21 CFR Part 11, Annex 11).
* Ability to develop and execute validation protocols and reports.
* Capable of troubleshooting validation and system issues.
* Experience with DCS systems (e.g. Emerson DeltaV) is a strong advantage.
Soft Skills
* Strong communication skills (written and verbal) in English and Dutch.
* Able to work independently, with a proactive and fast‑learning mindset.
* Structured, detail‑oriented and able to execute activities according to plan and deadlines.
* Team player, able to collaborate with QA, IT, Engineering and Business stakeholders.
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.