Requirements: English
Company: CareerWallet
Region: Braine-l''Alleud , Walloon Region
Contracting Brabant Wallon 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. 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. Jefferson Wells offers you a permanent cont... Trackwise, Engineering Project, GAMP, Provide Guidance, Pcs7, Software Updates, GMP, Platforms, Documentation, Communication, Risk Analysis, Quality Procedures, Strategies, Cyber Security, Data integrity, Manufacturing, Validation, Test plans, 21 CFR Part 11, Laboratory Work, Projects, ImPACT, Regulation, Production System, Pragmatism, Hardware, Engineering, VOS, Networks, Veeva, Exposure, Test Strategy, Remediation, Traceability, SCADA, GxP, Change Management, System Life Cycle Originele vacature is te vinden op StepStone.be Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carriretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d''emploi est disponible sur stepstone.be Crez maintenant votre Job Agent sur StepStone et trouvez le job de vos rves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrire sur stepstone.be!
CRWL1_BE