Sr. Specialist, IT Validation Services
Core
Ensuring 'fit for use' of IT applications and infrastructure across GxP business areas through Computer System Validation (CSV) and Qualification activities before production release.
Role type
Senior IC IT Validation Specialist (Pharma GxP)
Builds
Validated IT applications, infrastructure, and hardware for pharmaceutical production and regulatory systems.
Domain
Pharmaceutical industry, IT Compliance, GxP regulations
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Computer Systems Validation (CSV), GxP regulations, risk & impact assessment, test management tools (ALM), Electronic Records/Signature regulations, Data Integrity, GAMP methodology, IT infrastructure knowledge, project management
Preferred skills
Test automation, experience with CTMS/eTMF/ServiceNow/Veeva/SAP/MES/PV systems
Technologies
ALM, ServiceNow, Veeva, SAP, MES, PV, cloud, networks, operating systems, databases
Responsibilities
Participate in CSV activities for applications across multiple GxP business areas, Conduct risk & impact assessments to determine validation scope, Author CSV deliverables including Plans & Summary Reports, Support inspections and audits (internal and external), Conduct periodic reviews to ensure compliance, Support CSV staff across defined GxP business unit applications
Seniority
Senior, hands-on IC with management responsibilities