Upstream Lead

Our client, a global pharmaceutical manufacturing organization, is 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.

• CQV 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 Reports
• During 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 system
• Liaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS system
• Aligning with Construction Management vendor and CQV Turnover Lead in relation to System boundaries and Lead and review exercise

• Extensive CQV Upstream Equipment experience on Large Scale Projects
• SME on all Upstream Systems
• Working knowledge of ASTM E2500 / Leveraging Verification process
• Experience with liaising with other departments and building PMs/leads

If you are interested, please apply now for immediate consideration and further information.