System Validation Engineer

Company: Fusion Life Sciences Technologies

Work Type: Remote

Hours: Minimum 6 hours/day aligned to US time zones (EST/CST preferred)

Experience: 5–6 years

Role Overview

Fusion Life Sciences Technologies is seeking a Computer System Validation (CSV) Specialist with strong LabWare LIMS experience to support regulated pharmaceutical and life sciences clients. This role will lead and execute validation activities to ensure compliance with GxP, 21 CFR Part 11, and data integrity standards, working independently on complex systems.

Key Responsibilities

Execute and manage CSV activities for software, systems, and process changes

Serve as LabWare LIMS SME

Lead validation documentation (URS, FRS, RA, IQ/OQ/PQ, TM, VSR)

Support change control, validation reviews, and cross-functional meetings

Support Agile QA / testing within validation projects

Prepare validation reports and...