Commissioning, Qualification & Validation Engineer (HFD)

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

Were 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 Youll 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.