CQV Engineer

CQV Engineer – US, North Carolina – Initial 6-Month Contract – Life Sciences

Our client, a global pharmaceutical manufacturing organization is seeking an experienced CQV Engineer (Column Packing) to support the delivery of their large-scale CAPEX project based in North Carolina. 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.

What you'll do:

• CQV Engineer supporting Column Packing and associated Downstream Processing systems across DSM 3 and DSM 4.
• Support review of all design deliverables including drawings, datasheets, specifications, vendor documentation, and engineering packages.
• Generate and execute CQV lifecycle documentation including DQs, RTMs, QRAs, FATs, SATs, IOCs, IOQs, and Final Reports.
• Support commissioning, startup, and qualification activities for chromatography and column packing systems.
• Participate in vendor package reviews and support technical assessments for downstream processing equipment.

What you'll need:

• Bachelor's Degree in Engineering, Life Sciences, or related technical discipline.
• Extensive CQV, Validation, Commissioning, or Qualification experience within pharmaceutical or biotechnology projects.
• Hands-on experience with Column Packing activities in large-scale GMP manufacturing facilities.
• Experience supporting chromatography systems and downstream processing equipment.
• Understanding of GMP regulations and equipment qualification methodologies.
• Familiarity with FAT, SAT, IOQ, Risk Assessments, and validation lifecycle documentation.

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

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