CQV Downstream Engineer - Pharma Validation & Commissioning

Quanta Consultancy Services Ltd; North Carolina; Presencial; USD 80.000 - 100.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CQV

Validation

Commissioning

GMP regulations

Downstream processing equipment

Educación

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

Descripción del empleo

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.