Downstream Process Engineer

CEVA Logistics; Beaucouzé; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Ceva Animal Health seeks a hands-on Downstream Process Engineer to develop, optimize, and scale downstream purification for synthetic RNA/DNA. You will drive chromatography/TFF method development, ensure GMP documentation, and validate column and flow‑path reuse while collaborating with R&D, QA, and Manufacturing.

The role requires MSc/Engineer/PhD in Bioprocess/biotech, 3–7+ years downstream experience, AKTA expertise, and fluent English in a regulated, cross‑functional setting.

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.

Responsabilités

• 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.

Connaissances

RNA purification

Chromatography

TFF

GMP operations

Technical writing

Cross-functional collaboration

Analytical thinking

English fluency

Formation

MSc/Engineer/PhD: Bioprocess/biotech/Biochemistry degree

Outils

AKTA systems

DOE/statistical tools

Description du poste

Downstream Process Engineer

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a \"One Health\" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Yourmissions :

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.

Yourprofile :

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