CQV Downstream Engineer

QCS Staffing Ltd; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

Quanta Consultancy Services Ltd is seeking a talented CQV Downstream Engineer for a 7-month contract in North Carolina. This role offers a unique opportunity to contribute to an exciting new manufacturing facility on the East Coast.

Responsibilities include reviewing design deliverables and generating CQV documentation. The ideal candidate will possess a Bachelor's degree in Engineering or Life Sciences and have extensive experience in validation and commissioning within pharma or biotech settings.

Qualifications

• 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.

Responsibilities

• Support review of all Design deliverables including Drawings, Datasheets, specifications and Engineering Lists.
• Generate all CQV DST Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
• Generate DST Bridging document, ensuring alignment with Process Science (PS).
• Support vendor review activities for all DST Vendor Packages.

Skills

CQV

Validation

Commissioning

GMP regulations

Downstream processing equipment

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

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.

Responsibilities

• 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.

Qualifications

• 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.