Downstream Process Engineer

Downstream Process Engineer

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.

Qualifications

• MSc/Engineer or PhD: Bioprocess/biotech/Biochemistry degree.
• 3–7+ years hands‑on downstream processing experience.
• Expertise in RNA/DNA purification, chromatography & TFF.
• Strong command of AKTA method development & troubleshooting.
• Experience in column regeneration & reuse validation.
• Solid understanding of GMP operations & documentation.
• Rigorous, analytical, detail‑driven; excellent technical writing.
• Fluent in English; comfortable in cross‑functional, regulated environments.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, or veteran status.