OVERVIEW:
Our client is looking for a CQV engineer to support a new fill-finish manufacturing line at their Carolina site.

SCOPE & RESPONSIBILITIES:
• Lead risk-based CQV for a new fill-finish line: drive URS and design reviews, support FAT/SAT, and author and execute IQ OQ PQ for formulation, compounding, sterile filtration, filling stoppering, capping, inspection, and packaging, including isolator or RABS systems.
• Own aseptic readiness and documentation quality: support media fill and aseptic process simulation planning, EM and cleanroom qualification, CCI strategy alignment, data integrity controls, and deviation CAPA closure while keeping turnover inspection-ready and on schedule.
• Support SOPs, master batch records, and maintenance plans

SPECIAL REQUIREMENTS:
• 5 plus years CQV in aseptic fill-finish with knowledge of Annex 1 and FDA cGMP expectations
• Experience with utilities and facilities (WFI, clean steam, HVAC), and exposure to automation or CSV and e-validation platforms

LOGISTICS:
Scheduled from Feb 2026 to Jan 2028
Fully Onsite
40 hours a week