CSV Engineer
Contracting – Brabant Wallon
Your responsibilities:
The mission will be to support the validation and compliance aspects of remediation projects impacting laboratory equipment and software (e.g., OS upgrade, software updates, replacements).
You will work closely with site CSV leaders and IT/engineering project teams to define appropriate validation strategies and ensure compliance of remediation activities with GxP regulations.
- Analyze the impact of remediation actions (e.g., OS upgrade, software change, equipment replacement) on validated state.
- Define and document the validation strategy (CSV risk assessment, test strategy, acceptance criteria).
- Support the creation or update of validation deliverables (Plan, Risk Assessment, Test Plan, Summary Report, etc.).
- Collaborate with cross-functional teams: Quality, IT, Engineering, Lab Users, and Project Leads.
- Ensure that activities follow quality procedures and applicable regulations (GAMP 5, 21 CFR Part 11, EU Annex 11, etc.).
- Provide guidance on compliance expectations and propose pragmatic validation approaches based on risk and criticality.
- Ensure proper documentation and traceability of decisions throughout the validation lifecycle.
Your profile:
- Minimum 3 years of experience in CSV in regulated environments (GxP, ALCOA+, Data Integrity).
- Experience with laboratory instruments and associated software (standalone or networked).
- Knowledge of IT system lifecycle, including OS upgrades, software patches, and hardware obsolescence.
- Fluent French oral communication, to interact with on-site teams (scientists, quality, technicians).
- Rigorous, autonomous, and reliable, with the ability to assess situations and propose actionable plans.
Nice to haves:
- Previous involvement in cybersecurity or IT remediation projects in pharma or similarly regulated industries.
- Experience with GMP environments and understanding of validation processes for production systems.
- Exposure to manufacturing systems (PCS7, SCADA, PLCs) and their qualification constraints.
- Familiarity with digital documentation platforms (e.g., Veeva Vault, TrackWise).
- Experience with change management and ability to guide non-CSV experts through compliance steps.
Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
