Computer System Validation (CSV) Automation Engineer
: Job Details :

ROLE - Computer System Validation (CSV) Automation Engineer WORK AUTH - All Except H1B RATE - $80/hr on C2C CLIENT- Mid-size Biotech organization (leader in the CDMO realm whose focus is to combine technical leadership in cell culture, microbial fermentation, and cell and gene therapy) HYBRID SCHEDULE 2-3 days on-site, Holly Springs, NC CONTRACT - 19-month project.JOB DESCRIPTIONProject description: Our client has identified a gap within their team and has decided that they need to bring in a highly skilled computer systems validation (CSV) Automation Engineer to their growing team needs. This individual will be working under the supervision of the associate director of automation on the CSV team and will be apart of this growing team that supports the Holly Springs North Carolina site. This project is expected to run until February of 2025 for a total duration of 19 months as the expansion efforts continue throughout this location. Required Skills: •The ideal candidate will have 5+ years of direct Computer Systems Validation experience in a cGMP pharmaceutical facility working with FDA regulations •The ideal candidate will have knowledge of Automation control systems, Manufacturing & IT Systems & methodologies including (ASTM2500, GAMP5, Data Integrity and application of 21 CFR Part 11 •The ideal individual would have a bachelor's degree in either Chemical Engineering, Computer Engineering, Biological Science or the Technical equivalent Desired Skills: •Working knowledge of Kneat validation software •Knowledge with Drug Substance Manufacturing (DSM) Drug Product (DP) and/or Finished Goods Manufacturin