Commissioning & Qualification Lead (Raleigh)Staftonic LLC • Raleigh, NC, US
Commissioning & Qualification Lead (Raleigh)
Staftonic LLC • Raleigh, NC, US
1 day ago
Job type
- Part-time
Job description5+ years of CQV / Validation experience in pharmaceutical or biotech manufacturing. Strong background in aseptic / sterile filling line systems. Solid understanding of CSV, GAMP5, and cGMP principles. Excellent communication and leadership skills.
Title : Commissioning & Qualification Lead
Location : Raleigh, North Carolina
Responsibilities :
- Lead and execute CQV activities for filling line equipment including Rotary Washer, Depyrogenation Tunnel, Aseptic Filler Isolator, Lyophilizers, and Cappers.
- Review and approve validation deliverables (URS, FRS, Validation Plans, IQ / OQ / PQ protocols / reports, RTM).
- Oversee project timelines and ensure compliance with GMP, GAMP5, and 21 CFR Part 11.
- Provide CSV and automation support for control systems.
- Collaborate with cross-functional teams to meet quality and project objectives.
Qualifications :
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Lead Commissioning • Raleigh, NC, US