Industrialization Manufacturing Engineer (f/m/d)
Core
Execute industrialization activities for manufacturing lines, equipment, processes, and injection tooling to support life sciences, diagnostics, and biotechnology production.
Role type
Industrialization Manufacturing Engineer
Builds
Manufacturing lines, equipment, processes, and injection tooling for life sciences, diagnostics, and biotechnology
Domain
Life Sciences / Diagnostics / Biotechnology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
URS preparation, full industrialization set-up, process validation, equipment qualification, risk analysis (pFMEA), supplier identification, change control management, planning and budget execution
Preferred skills
Regulated environment experience (Life Sciences, Automotive, Aerospace), industrialization process/product experience, qualification/validation activities (V-cycle)
Technologies
None explicitly stated
Responsibilities
Prepare URS in collaboration with process owners; Execute full industrialization set-up including routing, work instructions, standard work, maintainability, EHS compliance, process validation, and equipment qualification; Manage long-term actions to support manufacturing routine; Identify suppliers from RFQ to onboarding and delivery; Manage full change control from redaction to closure; Plan and execute budget for project scope; Collaborate with associates from all functions (MPL, QC, QA, Production, Maintenance, R&D, EHS, global team)
Seniority
Mid-Senior, hands-on IC
