CQV Downstream Engineer

CQV Downstream Engineer - US, North Carolina - 7 Month Contract

Our client, a global pharmaceutical manufacturing organization, is looking for a talented CQV Downstream Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and 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 Engineer for Equipment in the Downstream Area, responsible for supporting review of all Design deliverables including Drawings, Datasheets, specifications and Engineering Lists.
• Support generation of all CQV DST Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
• Support generation of DST Bridging document, ensuring alignment with Process Science (PS) in relation to supply of CPDs and CQAs.
• Support vendor review activities for all DST Vendor Packages and act as CQV Engineer for all DST Systems.

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Extensive experience in CQV, validation, commissioning, or related roles within pharma or biotech environments.
• Exposure to Downstream processing equipment, including filtration, chromatography, buffer/media systems, and process support equipment.
• Basic understanding of GMP regulations (FDA, EMA, GAMP) and downstream validation requirements.