Downstream Process Engineer

About the Role Based at CEVA Santé Animale – Biogenovac (Pays de la Loire), this hands‑on role focuses on developing, optimizing, and scaling downstream purification processes for synthetic RNA/DNA. You will drive chromatography/TFF method development, ensure GMP‑compliant documentation, and lead validation of column and flow‑path reuse while collaborating across R D, QA, and Manufacturing. Principal Missions - - Design, optimize scale purification processes for synthetic RNA/DNA using advanced chromatography (AEX/CEX, affinity, multimodal, SEC, HIC) and TFF. - Develop scale‑down models, define CPPs/CQAs, and apply DOE/statistical tools to ensure process robustness. - Operate troubleshoot AKTA systems (Pure, Avant, Pilot, Ready); develop methods, gradients, and in‑line monitoring strategies. - Author and execute CIP/SIP, regeneration, sanitization, and storage protocols for pre‑packed and self‑packed columns. - Lead column and flow‑path reuse validation, including HETP/asymmetry testing, lifetime studies, pressure‑flow curves, and cleanliness verification. - Design and implement sterile filtration strategies (0.22 µm), perform integrity testing, and support validation activities. - Contribute to GMP‑regulated scale‑up, tech transfer, equipment qualification, deviations/CAPAs, and resin lifecycle management. - Maintain audit‑ready documentation (SOPs, batch records, protocols, study reports) aligned with ALCOA+ and QbD principles. - Collaborate cross‑functionally with Upstream, QC/Analytical, QA/Validation, Engineering, and Manufacturing to ensure robust, right‑first‑time operations.