Validation Manager

Must Haves: Must be from Pharmaceutical Background Must have Sterile injectable experience Minimum 5 years in a management role in Validation in pharmaceutical industry. Validation Master Plan Development / Update – VMP, CVMP Develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, VQs Validation of: Autoclaves, Depyrogenation Tunnels, Stability / Incubator / Refrigeration Chambers, Cleaning Equipment / Processes, Analytical Instruments, Facilities, Media Fills, Smoke Studies, Kaye Instrumentation Knowledge of cGMP requirements on validation methods and principals including FDA, ISPE, GAMP guidelines and FDA, CFR Part 11 Position Summary: Provide expertise, guidance, and oversight for the Validation efforts at Rising Facility. Ensure the development and implementation of the Rising Validation Department and the Site Validation Master Plan. Effectively oversee industry "best practices" using resources, such as ISPE and PDA and continuously upgrade the Site's validation practices and procedures. Manage site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff, and internal departments including outside contractors and vendors, as applicable. Job Type: Full-time Pay: $120,503.00 - $122,731.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: 8 hour shift Education: Bachelor's (Preferred) Experience: Sterile Injectables: 3 years (Required) Work Location: In person