Upstream Lead

Upstream Lead - US, North Carolina - 7 Months Initial ContractOur client, a global pharmaceutical manufacturing organization are looking for a talented CQV Upstream Lead to join their expanding team. With continued organizational growth and considerable investment across their portfolio of capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.What You'll DoCQV Lead Engineer for all Upstream systems (Inoc, Media, Cell Culture, Harvest), initially responsible for timely review and approval of all CQV documentation, including but not limited to – DQ/IQ, SIA, FAT, RTM, QRA, RVQ, SAT, IOC, TOC and final ReportsDuring BOD Stage, review of all design deliverables, including Drawings, Datasheets, specifications and Engineering Lists. Also assist in GMP reviews. Author all CQV sub plans (VPP) for Upstream areas. Review of all GMP generated documentation via the validation systemLiaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS systemAligning with Construction Management vendor and CQV Turnover Lead in relation to System boundaries and Lead and review exerciseWhat you'll need:Extensive CQV Upstream Equipment experience on Large Scale ProjectsSME on all Upstream SystemsWorking knowledge of ASTM E2500 / Leveraging Verification processExperience with liaising with other departments and building PMs/leadsIf you are interested, please apply now for immediate consideration and further information.