Staftonic LLC
Title: Senior CQV Engineer
Location: Durham, North Carolina
Long Term Project
Key Responsibilities: Lead and execute CQV activities for filling line equipment, including Rotary Washer, Depyrogenation Tunnel, Aseptic Filler Isolator, Lyophilizers, and Cappers. Develop, review, and approve validation documentation
URS, FRS, Validation Plans, IQ/OQ/PQ protocols and reports, RTM, and supporting records. Ensure all activities comply with GMP, GAMP 5, and 21 CFR Part 11 requirements. Manage timelines, resources, and deliverables to align with project objectives. Provide technical and CSV support for automation and control systems. Collaborate cross-functionally with Quality, Engineering, and Operations teams to achieve project and compliance goals. Qualifications: Minimum 5 years of experience in CQV or equipment validation within pharmaceutical or biotech manufacturing. Proven expertise in aseptic and sterile filling line systems. Strong understanding of CSV principles, GAMP 5, cGMP, and FDA regulations. Excellent leadership, problem-solving, and communication skills. Ability to manage multiple priorities in a fast-paced, compliance-driven environment.
Key Responsibilities: Lead and execute CQV activities for filling line equipment, including Rotary Washer, Depyrogenation Tunnel, Aseptic Filler Isolator, Lyophilizers, and Cappers. Develop, review, and approve validation documentation
URS, FRS, Validation Plans, IQ/OQ/PQ protocols and reports, RTM, and supporting records. Ensure all activities comply with GMP, GAMP 5, and 21 CFR Part 11 requirements. Manage timelines, resources, and deliverables to align with project objectives. Provide technical and CSV support for automation and control systems. Collaborate cross-functionally with Quality, Engineering, and Operations teams to achieve project and compliance goals. Qualifications: Minimum 5 years of experience in CQV or equipment validation within pharmaceutical or biotech manufacturing. Proven expertise in aseptic and sterile filling line systems. Strong understanding of CSV principles, GAMP 5, cGMP, and FDA regulations. Excellent leadership, problem-solving, and communication skills. Ability to manage multiple priorities in a fast-paced, compliance-driven environment.