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Downstream Process Engineer


Ceva Santé Animale
7 days ago
Posted date
7 days ago
N/A
Minimum level
N/A
Full-timeEmployment type
Full-time
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 Heath 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
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JOB SUMMARY
Downstream Process Engineer
Ceva Santé Animale
Beaucouzé
7 days ago
N/A
Full-time

Downstream Process Engineer