Validation Specialist IS (GxP) -CDI- F/M

Job description

Who we are ? We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement". Your mission R&D Pharma Pierre Fabre is hiring in Toulouse (Langlade, Oncopole) a Validation Specialist IS to be responsible for ensuring that GxP Information Systems—on premise and cloud based—are validated, compliant, and maintained in a validated state throughout their lifecycle, in line with regulatory requirements and internal Quality standards. The role supports both RUN and CHANGE activities for R&D Pharma systems and plays a key role in modern validation approaches, including cloud environments (e.g. AWS or AZURE) and scripted / automated validation, while ensuring audit and inspection readiness. Your role within a pioneering company in full expansion: IS Validation & Compliance Apply and maintain the Group IS validation framework on R&D Pharma systems, including cloud-based GxP platforms. Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, Annex 11, and internal Quality procedures. Act as a validation point of contact for IS projects and operational activities. System Lifecycle Management (On‑Premise & Cloud) Contribute to validation activities during system implementation, upgrades, and cloud evolutions: Risk assessments and impact analyses Validation plans adapted to IaaS, PaaS and SaaS models IQ / OQ / PQ strategies, including scripted and automated validation tests Traceability matrices Assess and challenge vendor validation approaches, including automation, CI/CD pipelines, and cloud-native architectures. Cloud Validation & Automated Qualification Define, review, and approve risk-based validation strategies for cloud environments (e.g. AWS). Leverage Infrastructure as Code and scripted controls as part of Installation Qualification and validation evidence. Evaluate and use supplier documentation and cloud provider compliance evidence within a shared responsibility model, ensuring regulatory acceptability. Ensure that validation remains efficient, proportionate, and inspection‑ready in highly automated and evolving environments. Maintenance of the Validated State (RUN) Ensure ongoing compliance of validated systems, including cloud solutions, through: Change and incident impact assessments Periodic reviews adapted to SaaS / cloud solutions Access management and audit trail reviews Business Continuity and Disaster Recovery validation considerations Support deviation management and CAPA activities related to validated systems. Documentation & Quality Records Create, review, and maintain validation documentation in approved ALM / documentation tools. Ensure validation evidence remains up to date, risk‑based, and aligned with cloud and automated practices. Contribute to Quality documentation (SOPs, Work Instructions, templates). Cross-functional Collaboration Work closely with IS teams, Quality Assurance, business stakeholders, cloud providers, and external vendors. Support internal and regulatory audits, including explanation and defence of cloud and scripted validation approaches. Scope of Systems (non-exhaustive) Clinical and regulatory systems Laboratory and R&D Pharma Information Systems Cloud-based GxP platforms (IaaS, PaaS, SaaS – e.g. AWS) Data and analytical platforms with automated validation components This position is compatible with teleworking up to 2 days a week according to company rules. We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation... Who you are ? Your skills at the service of innovative projects: Master’s degree in IT, Quality, Life Sciences, or equivalent. Minimum 5 years’ experience in IS validation / CSV in a GxP-regulated environment. Demonstrated experience with cloud system validation and maintenance of validated state. Technical & Regulatory Skills · Strong knowledge of: o Computer System Validation (CSV) o GAMP 5 (risk-based approaches) o 21 CFR Part 11 / Annex 11 · Proven experience with: o Validation of cloud and SaaS solutions o Scripted and automated validation / testing o Supplier assessments and shared responsibility models · Languages English: C2 French: Fluent At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.