On-site GxP Informatics & CSV Specialist (LIMS/ELN)

Pharmaron Beijing Co. Ltd.

Coventry (RI)

On-site

USD 80,000 - 120,000

Full time

5 days ago

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Benefits offered by this job

Medical Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Pharmaron Beijing Co. Ltd. seeks a Computer System Validation/QC Informatics Specialist to support laboratory data systems within QC & Analytical. You will manage CSV lifecycle, qualify GxP systems, and collaborate with IT and QA to ensure data integrity and compliance.

The role focuses on LIMS/ELN/SDMS platforms, data workflows, and system upgrades. On-site in Coventry, RI, with visibility to audits and continuous improvement of pharmaceutical informatics in a global CRO/CDMO.

Qualifications

MSc or BS in Chemistry or CS required; 5+ years GxP experience preferred.
Experience in IT supporting role with data terminology and lab workflows.
Direct experience with laboratory informatics (LIMS) systems.

Responsibilities

Lead qualification activities as part of CSV lifecycle (IQ/OQ/PQ).
Support GxP software upgrades, installations, and rollouts with IT and QA.
Maintain data integrity and adherence to 21 CFR Part 11 and data integrity principles.
Provide user training and liaise between IT and lab staff to prioritize needs.
Assist audits and regulatory inspections as directed.