Senior Platform & Validation Engineer (GxP / CSV)

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

Overview

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 application within a GxP-regulated environment, ensuring full compliance with Computer System Validation (CSV) standards.

This is a hands-on role combining infrastructure/platform engineering with validation expertise, working closely with QA and project stakeholders to deliver a compliant, inspection-ready system.

Key Responsibilities

• Lead the re-platforming of an application onto a Linux-based enterprise environment (RHEL) with a SQL Server backend
• Design, build, and deploy a compliant infrastructure stack
• Execute and support Computer System Validation (CSV) activities across the full lifecycle
• 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
• Collaborate with QA, security, and project teams to ensure inspection readiness
• Review and produce validation and technical documentation (URS, FS, DS, traceability matrices, validation reports)
• Work with existing configurations (e.g. Git-based) to replicate and modernise system architecture

Required Experience

• Proven experience in GxP-regulated environments (pharma, biotech, life sciences)
• Strong background in Computer System Validation (CSV)
• Hands-on delivery of qualification lifecycle (IQ/OQ/PQ/MQ)
• Experience with Linux-based platforms (ideally RHEL) and SQL Server
• Solid understanding of:
  • Data integrity principles (ALCOA++)
  • Change control processes
  • Environment separation (Dev/Test/Prod)
• Ability to work across both technical engineering and validation documentation

Preferred Backgrounds

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

• Platform / Infrastructure Engineering within pharma
• Validation Engineering with technical stack exposure
• Senior DevOps Engineering in GxP environments
• CSV or GAMP5-focused architecture roles

Nice-to-Have Skills

• Experience with bioinformatics or clinical data environments (e.g. CDISC/SDTM)
• Exposure to R / RStudio / RShiny pipelines
• Experience with identity integration (e.g. Active Directory)
• Migration experience from open-source to enterprise platforms

Logistics

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

Interested?