Contract | Remote (Europe-based) | Initial 3 months

We are supporting a leading international Pharma organisation on a critical project requiring an experienced Senior Platform & Validation Engineer. This role focuses on re-platforming a business-critical biomarker application within a GxP-regulated environment, ensuring full compliance with Computer System Validation (CSV) standards.

This is a hands-on role combining platform engineering, application stack deployment, and validation expertise. The successful candidate will be responsible for building and deploying application platforms from the ground up, working closely with QA and project stakeholders to deliver a compliant, inspection-ready system.

• Lead the re-platforming of an application onto a Linux-based enterprise environment (RHEL) with a SQL Server Back End
• Design, build, and deploy application platforms and full application stacks from scratch
• Recreate and modernise systems using configuration-driven deployments (eg Git-based configurations, scripts, IaC)
• Set up and manage Dev/Test/Prod environments, ensuring repeatable and consistent builds
• Deliver infrastructure and platform architecture aligned with security, scalability, and corporate standards
• Execute and support Computer System Validation (CSV) activities across the full life cycle
• Deliver qualification documentation, including:
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • MQ (Migration Qualification)
• Ensure alignment with data integrity (ALCOA ), audit trails, and regulatory requirements
• Support application and database migration (SQL Server) ensuring integrity and performance
• Collaborate with QA, security, DevOps, and project teams to ensure inspection readiness
• Review and produce both technical and validation documentation (URS, FS, DS, traceability matrices, validation reports)

• Proven experience in GxP-regulated environments (pharma, biotech, life sciences)
• Strong background in Computer System Validation (CSV)
• Hands-on delivery of qualification life cycle (IQ/OQ/PQ/MQ)
• Demonstrated experience building application platforms or application stacks from the ground up
• Experience working with:
  • Linux environments (preferably RHEL)
  • SQL Server/database platforms
• Strong experience with:
  • System deployment, configuration, and migration
  • Environment setup and optimisation (Dev/Test/Prod)
• Understanding of:
  • data integrity principles (ALCOA )
  • audit trails and compliance requirements
  • change control processes
• Ability to operate across engineering execution AND validation documentation

Candidates with experience in one or more of the following will be highly relevant:

• Platform/Application Platform Engineering within pharma
• DevOps Engineering within GxP or regulated environments
• Infrastructure Engineers with strong application stack deployment experience
• Validation Engineers with hands-on platform or system build exposure

• Experience working with Git, CI/CD, or configuration-based deployments
• Exposure to bioinformatics or clinical data environments (eg CDISC/SDTM)
• Experience with R/RStudio/RShiny pipelines
• Knowledge of identity integration (eg Active Directory)
• Experience migrating systems from open-source to enterprise platforms

• Location: Remote (Europe)
• On-site requirement: Occasional travel to a European site (UK or France)
• Start Date: ASAP
• Contract Length: 3 months initial (extension likely)
• Workload: Full-time

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