CSV Engineer

Overview

On Site
Full Time

Skills

LIMS
Quality Management
Pharmaceutics
Staff Augmentation
Computerized System Validation
Test Scripts
SOP
Offshoring
Veeva
RIM

Job Details

Roles & Responsibilities:
  • We are now looking for a resource on the validation side of things going on here. Depending on the resource, we're looking for someone with (LabVantage) LIMS and quality systems validation experience, and/or general more broad Pharma/Biotech CSV experience that could back-fill as staff augmentation.
  • Engagement would be (at least) through the end of the year.
  • Potential in-scope activities.
  • i. CSV/Lab Systems Qualification document/deliverable authoring.
  • ii. Test script/protocol authoring (potential execution).
  • iii. SOP modification/authoring.
  • iv. Spreadsheet Validation.
  • For the right person: local/hybrid/on-site, remote, and offshore would all be considered.
  • i. Veeva (Quality, eTMF, RIM).
  • ii. Val Genesis.
  • iii. Lab Vantage.
  • iv. Various (Stand-Alone) Lab Computing systems.
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