LIMS Subject Matter Expert (SME) Opportunity – Seattle, WA
My client is seeking a LIMS Subject Matter Expert (SME) to join a global biotech company located near Seattle, Washington. The role will involve ownership of project management for LIMS, including data entry into the system and managing any associated procedural revisions.
Role ResponsibilitiesSystem Implementation & Configuration
* Lead requirements gathering from QC, R&D, and Manufacturing laboratories
* Configure LIMS workflows for sample management, stability studies, batch release, and analytical testing
* Integrate LIMS with laboratory instruments (HPLC, GC, LC-MS) and enterprise systems (ERP, MES, ELN)
Validation & Compliance
* Develop and execute Computer System Validation (CSV) protocols (IQ/OQ/PQ)
* Ensure compliance with 21 CFR Part 11, GAMP 5, and Annex 11
* Maintain audit trails, electronic signatures, and secure user access
Training & Support
* Deliver training to laboratory staff and system administrators
* Provide ongoing support for troubleshooting, upgrades, and change management
* If this opportunity may be of interest, please let me know. Alternatively, referrals are welcome if you know someone who may be a good fit.