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

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

Résumé du poste

Sandoz Biologics Toulouse recrute un ingénieur CQV pour gérer les activités de qualification liées à l’automatisation et aux systèmes OT/IT de fabrication. Vous définissez les plans de qualification et assurez la traçabilité et la conformité GMP/CSV.

Vous travaillez en équipe avec Production, Qualité et IT, et vous soutenez les essais et inspections réglementaires tout au long du cycle de vie des équipements.

Qualifications

• Diplôme en automatisation, IT industriel ou génie des procédés.
• Première expérience en qualification/validation dans un environnement réglementé.
• Connaissance des GMP, CSV et méthodologies GAMP5.

Responsabilités

• Définir les stratégies de qualification/validation conformément aux procédures internes.
• Créer et maintenir les documents de qualification/validation (plan de validation, IQ/OQ/PQ, matrices de traçabilité).
• Revoir les spécifications (URS, FS, HDS, FDS), FAT, SAT et maintenir l’état validé (ALCOA+).
• Soutenir les inspections réglementaires et les audits des clients.
• Collaborer avec Production, Maintenance, Automation/IT, Qualité et fournisseurs externes.

Connaissances

GMP

CSV

ALCOA+

Change Control

CAPA

Documentation

Data Integrity

Bilingue (Anglais/Français)

Formation

Automation / IT industriel / Génie des procédés (ou équivalent)

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.