Santa Ana, CA30+ days ago
A minimum of ten years of experience with increasing responsibility in validation/quality service and project management of life sciences, biotech, or other FDA regulated projects Project management experience involving scope, budget, schedule, quality, risk, and client management Diverse experience leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation (preferred) The ability to read engineering documents and experience in proposal development A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred) An understanding of good documentation practices, cGMP, and FDA validation methods and systems A working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity Strong project management software and word processing skills, and solid technical writing skills A passion for a career in the life science industry Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment A willingness to travel for project requirements including project installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions A bachelor of science in engineering or a related technical degree. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.