R&D Informatics Analyst (Contract)

About the role

The R&D Informatics Analyst supports day-to-day operations and project-based initiatives within cross-functional teams. The primary focus is managing daily operational activities, including IT Helpdesk support for end users and customers. Responsibilities include managing lab equipment and applications, troubleshooting hardware and software issues, performing computer system validation, ensuring data integrity and compliance, and administering system configuration, access management, security patching, and data backup processes.

Responsibilities

• Execute & comply with 4DMT SDLC, Change, Access, Inventory, & operational management procedures for business-critical applications & platforms.
• Support evaluation, pilot testing, selection, & ongoing management of IT vendors & partners aligned to business & compliance requirements.
• Lead or support validation of computerized systems & laboratory instruments, including installation, configuration, troubleshooting, & documentation (SOPs, IQ/OQ/PQ).
• Ensure ongoing data integrity, backup, & regulatory compliance for GMP laboratory & manufacturing systems.
• Provide technical input & support for Investigations, Change Controls, CAPAs, decommissioning, & audit readiness activities.
• Participate in or lead Periodic Reviews, User Access Reviews, & Audit Trail Reviews for GMP systems.
• Execute & support UAT activities, collaborating with IT & business teams on issue resolution.
• Deliver hands-on operational support for QC & Manufacturing instrument systems, including break/fix support & reliability issues in validated & production environments.
• Manage user account provisioning & deactivation in compliance with access control SOPs.
• Other duties as assigned.

Qualifications

• Education: Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field with at least 5+ years of relevant experience in a laboratory environment or biotech/pharma setting; or Master’s degree with 3–5+ years of relevant experience.
• Experience: Strong operational knowledge of laboratory IT environments, including instrument connectivity & client/server architectures; proficiency in Windows OS administration; working knowledge of network technologies; familiarity with virtualization platforms; experience supporting validated systems in a regulated GxP environment; knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process; familiarity with broad range of lab instrumentation and Enterprise IT solutions used in Biopharma.