Commissioning, Qualification & Validation Engineer (H/F/D)

Evotec; Toulouse; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Evotec recrute un(e) ingénieur CQV à Toulouse pour piloter les activités de qualification et validation liées à l’automatisation et aux systèmes de production. Vous évaluerez l’impact des changements et assurerez les requalifications nécessaires, en conformité avec GMP et les standards GAMP 5.

Vous travaillerez en étroite collaboration avec les équipes Production, Maintenance et Qualité, et participerez aux inspections et audits clients, tout en maintenant une documentation précise et à jour

Qualifications

• Connaissance des GMP et de la CSV (EU GMP Annex 11, 21 CFR Part 11).
• Maîtrise des systèmes de qualification/validation et des documents associées (IQ/OQ/PQ).
• Capacité à rédiger des documents techniques clairs et conformes.
• Expérience en gestion de changements, déviations et CAPA dans un environnement industriel.

Responsabilités

• Définir les stratégies de qualification/validation selon les procédures internes et assurer les livrables (plans, rapports, matrices de traçabilité).
• Gérer les essais et la documentation associée tout au long du cycle de vie des équipements OT/IT.
• Contribuer à la gestion des écarts, CAPA et améliorations qualité; soutenir les inspections et audits.
• Travailler avec Production, Maintenance, Automation/IT et Qualité pour maintenir l’état validé et l’intégrité des données (ALCOA+).

Connaissances

GMP knowledge

CSV knowledge

ALCOA+

Change control

CAPA management

Technical writing

Cross-functional collaboration

Bilingual FR/EN

Formation

Degree en automation / IT industriel

Outils

PLC

SCADA

HMI

Description du poste

Titre du poste : Commissioning, Qualification & Validation Engineer
Lieu : Toulouse
Département : MSAT
Type de contrat: CDI
JOB ID: 14858

We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact on the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine!

About the Role

On Sandoz Biologics Toulouse site, within the MS&T – Commissioning, Qualification & Validation (CQV) team, your mission is to manage qualification activities and documents related to automation (OT) and software driving manufacturing systems. For each change or incident, you assess the qualification impact, define and drive the appropriate (re)qualification, and keep documentation and the validated state up to date, in compliance with GMP (EU Annex 11, GAMP 5 good practices).

What You’ll Do

• Within the computerized systems and OT domain:
• Define qualification/validation strategies according to internal procedures
• Create and maintain qualification/validation documents: e.g., validation plan, impact assessments, IQ/OQ/PQ protocols and reports, traceability matrix
• Review specifications (e.g., URS, FS, HDS, FDS), FAT, SAT
• Follow up and process quality events (change controls, deviations, CAPAs) on the OT/software scope of production equipment, throughout their lifecycle.
• Maintain the validated state (periodic reviews, documentation lifecycle, action-plan follow-up) and ensure data integrity (ALCOA+).
• Provide technical support in deviation management (root-cause analysis, CAPA) and contribute to technical standards and SOPs.
• Support regulatory inspections and customer audits.
• Work closely with Production, Maintenance, Automation/IT, Quality and external vendors/integrators.

Who You Are

• Degree in Automation, Industrial IT, Process Engineering, or a related field.
• First experience in qualification/validation activities or within a regulated industrial environment.
• Knowledge of GMP, CSV regulations (EU GMP Annex 11, 21 CFR Part 11), and GAMP 5 methodologies.
• Familiarity with PLC, SCADA, HMI, and IT/OT environments.
• Experience with change control, deviations, CAPA management, and risk assessments (FMEA).
• Strong technical writing and documentation skills.
• Understanding of data integrity principles (ALCOA+).
• Fluent in English and French.
• Collaborative mindset with the ability to work effectively across multidisciplinary teams.

Key Skills: GMP CSV Risk Management Data Integrity (ALCOA+) Change Control Deviations & CAPA Technical Documentation Cross-Functional Collaboration.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.