Manager, Production Support, API Manufacturing System Engineering, HIkari Site / 光工場 医薬品原薬製造サポート システムエンジニア (課長代理)
Core
Manager of System Engineering responsible for API drug substance manufacturing support, process optimization, and technical service activities at the Hikari site using DCS/MES systems.
Role type
Manager, Production Support, API Manufacturing System Engineering
Builds
API drug substance manufacturing processes and technical services at the Hikari site
Domain
Biopharmaceuticals / API Manufacturing / Process Control Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing support, DCS/MES system expertise, process validation, root cause analysis, data analytics for process optimization, cross-functional team leadership, vendor management, troubleshooting automation systems
Preferred skills
EHS management experience, ISO 14001/45001 knowledge, chemical process technology knowledge
Technologies
DCS, MES, automation control systems
Responsibilities
Manage cross-functional teams for GMP manufacturing of API products; execute project milestones for equipment readiness and batch production; investigate manufacturing deviations and implement CAPA; trend process performance and execute data analytics for optimization; author technical reports and protocols for GMP activities; identify and implement process performance improvements; manage external vendors for equipment and services delivery
Seniority
Manager, hands-on IC with team leadership
