A passion for a career in the Life Science industry
Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
Experience with financial systems, project, and client administration
Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
Diverse experience in leading 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 is desirable.
Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
Project Management experience in managing scope, cost, schedule, quality and risk is required.
Experience in mentorship and multi-discipline collaboration
Displayed leadership in a consulting and service environment
Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
BS Degree in Engineering or related technical degree.