Process Engineer II

Role: Process Engineer supporting manufacturing within the Skin Value Stream, focused on process optimization, validation, and lifecycle management to enhance efficiency, quality, and cost-effectiveness. Responsibilities include cross-functional collaboration with EHS, R&D, quality, regulatory, and facilities teams; leading engineering studies and validations; performing statistical analysis and process trending; executing investigations and CAPA; and developing training programs. Qualifications: Bachelor's in engineering with 2-6 years' experience; proficiency in statistical tools (e.g., SPC, Minitab); experience with lean Six Sigma, validation, and requalification; knowledge of GMP, ISO 13485, EU MDR, and medical device manufacturing. Preferred skills include project management, process improvement, and familiarity with cleaning validation. High-value specifics: supporting skin-related medical devices, working in a regulated GMP environment, with potential exposure to biohazardous materials, and involving process validations and lifecycle management. Work setup: not specified, but expected to include site-based work with potential travel for cross-location coordination.