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LIMS Subject Matter Expert (SME) Opportunity - Seattle, WA

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 Responsibilities System 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.

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