R&D Informatics Analyst (Contract)
Core
Managing daily operational activities and providing Tier 1/2 IT Helpdesk support for end users, customers, and lab equipment in a GMP environment.
Role type
IT Operations Analyst (GMP/Pharma)
Builds
Operational stability and compliance for business-critical applications and laboratory instruments
Domain
Biotechnology / GMP Manufacturing
Deliverable
infrastructure
Required skills
IT Helpdesk support, Computer System Validation (CSV), Change Control management, Data Integrity, GMP compliance, Vendor management, UAT execution, Break/fix support
Preferred skills
SDLC procedures, Audit readiness, Periodic Reviews, User Access Reviews
Technologies
GMP systems, Laboratory instruments, IT Helpdesk tools
Responsibilities
Execute and comply with SDLC, Change, Access, Inventory, and operational management procedures for business-critical applications and platforms; Support evaluation, pilot testing, selection, and ongoing management of IT vendors and partners; Lead or support validation of computerized systems and laboratory instruments including installation, configuration, troubleshooting, and documentation (SOPs, IQ/OQ/PQ); Ensure ongoing data integrity, backup, and regulatory compliance for GMP laboratory and manufacturing systems; Provide technical input and support for Investigations, Change Controls, CAPAs, decommissioning, and audit readiness activities; Participate in or lead Periodic Reviews, User Access Reviews, and Audit Trail Reviews for GMP systems; Execute and support UAT activities collaborating with IT and business teams on issue resolution; Deliver hands-on operational support for QC and Manufacturing instrument systems including break/fix support and reliability issues in validated and production environments