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

Evotec; Toulouse; Sur place; EUR 52 000 - 76 000; Plein temps

Résumé du poste

Evotec recrutе un ingénieur Commissioning, Qualification & Validation (CQV) pour l site de Toulouse, dans l’équipe MSAT. Vous gérez les activités de qualification liées à l’automatisation et aux systèmes de fabrication, en conformité avec GMP et les exigences CSV.

Vous définirez les stratégies, créerez les plans et assurerai les rapports IQ/OQ/PQ, tout en soutenant les inspections et audits clients, et en collaborant avec les équipes Production, Maintenance et Qualité.

Qualifications

• Diplôme en automatisation, IT industriel ou génie des procédés.
• Expérience en qualification/validation ou en environnement industriel réglementé.
• Connaissance des GMP, CSV (EU Annex 11, 21 CFR Part 11) et GAMP 5.
• Familiarité avec PLC/SCADA/HMI et environnements IT/OT.
• Expérience en gestion des changements, déviations, CAPA et évaluation des risques.
• Excellentes capacités rédactionnelles et documentation.
• Compréhension des principes d’intégrité des données (ALCOA+).
• Bilingue anglais et français.
• Esprit collaboratif et travail en équipe pluridisciplinaire.

Responsabilités

• Définir les stratégies de qualification/validation selon les procédures internes.
• Créer et maintenir les documents de qualification/validation (IQ/OQ/PQ plans et rapports, traçabilité).
• Revoir les spécifications (URS, FS, HDS, FDS), FAT, SAT.
• Suivre les contrôles de changement, déviations et CAPA sur l’OT/logiciel.
• Maintenir l’état validé (revues périodiques, cycle documentaire).
• Apporter un soutien technique en gestion des écarts et contribuer aux SOPs.
• Soutenir les inspections réglementaires et les audits clients.
• Collaborer avec Production, Maintenance, Automation/IT, Qualité et fournisseurs externes.

Connaissances

CSV

Risk Mgmt

Data Integrity

Change Control

Deviations & CAPA

Tech Documentation

Cross-Functional

Formation

Baccalauréat / diplôme équivalent en automatisation ou 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.