Director, Manufacturing Science & Technology Engineering
Core
Lead the site's Manufacturing Science & Technology (MS&T) organization to ensure products are in an industry-standard validated state and maintain technical knowledge of manufacturing processes.
Role type
Director, Manufacturing Science & Technology Engineering
Builds
Validated medical device manufacturing processes and product lifecycle management
Domain
Medical device manufacturing (ophthalmic/eye care)
Required skills
Manufacturing validation, technology transfer, process risk management (pFMEA), statistical analysis, CAPA management, team leadership, succession planning, business continuity management
Preferred skills
Contact lens manufacturing experience, R&D background, new site start-up experience
Technologies
Site Master Validation Plan (SVMP), pFMEA, statistical analysis tools
Responsibilities
Ensure execution of Site Master Validation Plan activities and annual revalidation; Provide governance on validation activities; Manage product/process risk management and knowledge management; Lead technical deviation investigations and CAPA; Manage product/process transfers and 2nd sourcing projects; Manage MS&T team career path and training; Coordinate Business Continuity Management
Seniority
Director, strategic leadership with hands-on technical oversight
