Job Details
MannKind Corporation has an opening for a Senior Manager, Manufacturing Validation in Danbury, CT.
Duties: Maintain oversight of equipment and processes. Evaluate methodology. Maintain routine re-validation. Develop team. Utilize understanding of validation, cGMP, FDA, quality processes, and manufacturing. Lead others, understand and manage risks. Use database TrackWise, BlueMountain, MS suite of products, calibrated instruments, and data loggers, Ellab software, and electronic (MasterControl). Resolve technical issues. Provide technical solutions. Work directly with product owners, equipment owners, and subject-matter experts.
Requires: Bachelor's Degree in Pharmaceutical Sciences, or related pharmaceutical manufacturing field, or foreign equivalent. Must have at least 12 years of experience in manufacturing validation, or related position. 10 years of experience working with processes, quality change management, regulatory compliance, and validation lifecycle management. 5 years of experience with statistical analysis. 10 years of experience working to resolve complex technical issues, including resolutions to protocol deviations affecting validation and providing technical solutions. 10 years of experience working directly with product owners, equipment owners, and subject-matter experts. 10 years of experience with database management, JUMP, TrackWise, BlueMountain, MS Suite of products, calibrated instruments and data loggers, Ellab software, and electronic batch record system (MasterControl).
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