CQV Upstream Engineer

CQV Upstream Engineer – US, North Carolina – 7 Month Contract

Our client, a global pharmaceutical manufacturing organization, is seeking a talented CQV Upstream Engineer to join their expanding team. With continued organizational growth and significant investment across their portfolio and capital programs, this is an exciting opportunity to contribute to a brand-new manufacturing facility on the East Coast of the United States.

• CQV Engineer for equipment in the Upstream area, responsible for supporting the review of all design deliverables, including drawings, datasheets, specifications, and engineering lists
• Support generation of all CQV UST documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC, and IOQ, including final reports
• Support generation of UST bridging documents, ensuring alignment with Process Science (PS) regarding supply of CPDs and CQAs
• Support vendor review activities for all UST vendor packages and act as CQV Engineer for all upstream systems

• Bachelor’s degree in Engineering, Life Sciences, or a related field
• Extensive experience in CQV, validation, commissioning, or related roles within pharmaceutical or biotech environments
• Experience with upstream processing equipment, including bioreactors, fermentation systems, seed trains, media preparation, and associated process support equipment
• Basic understanding of GMP regulations (FDA, EMA, GAMP) and upstream validation requirements