Validation Specialist IS (GxP)-R&D Pharma - F/M

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...

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:
• Computer System Validation (CSV)
• GAMP 5 (risk-based approaches)
• 21 CFR Part 11 / Annex 11

Proven experience with:

• Validation of cloud and SaaS solutions
• Scripted and automated validation / testing
• Supplier assessments and shared responsibility models