Insight Global is looking for a Computer System Validation Specialist for a contract role with one of their pharmaceutical clients in Grand Rapids, MI. This person needs to be a well rounded individual within the computer system validation space within pharmaceutical industry. The CSV Specialist will be implementing Advanced Planning & Scheduling software into a developing Rockwell Automation-Pharmasuite MES system to smooth out, optimize, and increase productivity through MES system while maintaining proper regulations and compliance. They will be writing and reviewing validation plans, writing IQOQPQ reports, and coordinating cross-functionally throughout the duration of the project. This is an on-site, 5 days/week opportunity in Grand Rapids, MI.
- 5+ Years experience in pharmaceutical CSV experience with implementations
- Ability to work cross-functionally within multiple groups and understand end-user perspectives of the systems
- Strong experience and understanding of Master Control, MES systems, and SDLC of pharma systems
- Experience providing input for drafting/reviewing IOPQ's with vendors keeping 21 CFR Part 11/Annex 11 compliance intact
- Expert in pharmaceutical regulations and compliance through GAMP
- Ability to write and review validation plans for URS and FRS
- Experience integrating PlanetTogether Advanced Planning & Scheduling software with Rockwell Automation-Pharmasuite
- Working knowledge/experience with QAD or SAP
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.