Manufacturing, Product Development & QA Domain Architect
Core
Chief technological strategist driving future-state roadmaps for global Manufacturing, Quality, and Product Development system landscapes in the biopharmaceutical industry.
Role type
Senior IC Domain Architect (Manufacturing & Quality)
Builds
Enterprise-wide architecture for digital manufacturing, process automation, and information systems
Domain
Biopharmaceutical manufacturing (API/BDS, sterile fill-finish, medical devices) and Industrial IoT
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Enterprise Architecture (TOGAF), ISA-95/ISA-88 standards, MES (PAS-X), LIMS, SCADA, PLCs, Data Historians (OSIsoft PI), Serialization/Track & Trace, PLM, ERP (SAP), TCO analysis, Greenfield/Brownfield strategy, GxP compliance
Preferred skills
Biopharmaceutical/medical device manufacturing architecture experience, Industry 4.0 trends (Smart Manufacturing, IIoT, Edge Computing, AI)
Technologies
TOGAF, ISA-95, ISA-88, Werum PAS-X, OSIsoft PI, SAP
Responsibilities
Lead and mentor a team of 5–8 Technical Platform Owners and Solution Architects; Drive architectural governance across global IT landscapes; Act as strategic consultant on high-impact technology initiatives; Translate business vision into scalable technical designs; Architect digital solutions for diverse manufacturing networks; Benchmark technology stack and scout emerging Industry 4.0 trends; Ensure project resilience and risk mitigation; Manage relationships with global software vendors and system integrators; Present complex technology concepts to executive leadership
Seniority
Senior, hands-on IC with strategic leadership