Validation Specialist IS (GxP) CDI- FM

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 10000 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.

R&D Pharma Pierre Fabre is hiring in Toulouse (Langlade Oncopole) a Validation Specialist IS to be responsible for ensuring that GxP Information Systemson premise and cloud basedare 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 (OnPremise & 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 inspectionready 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 riskbased 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...

Your skills at the service of innovative projects:

Masters 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 companys 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.