Manager, Mechanical Engineer or Control & Instrumentation Engineer/Capital Capital Project Management, Hikari Site / 光工場 テクニカル・リード プロジェクトエンジニア
Core
Leading or supporting CAPEX projects for new equipment installation, major upgrades, and product expansion at the Hikari pharmaceutical manufacturing site, ensuring stable supply, quality, and compliance.
Role type
Manager, Capital Project Management (Mechanical/Control & Instrumentation)
Builds
Pharmaceutical manufacturing facilities and equipment lifecycle (introduction, operation, maintenance)
Domain
Biopharmaceutical manufacturing / Capital Engineering
Deliverable
Infrastructure
Required skills
Mechanical, electrical/instrumentation/control, or chemical engineering background; cGMP environment experience; equipment specification and URS development; vendor selection and procurement support; commissioning and qualification planning; stakeholder coordination and negotiation
Preferred skills
Chemical plant or pharmaceutical equipment engineering experience; automation and packaging machinery knowledge; project management in CAPEX contexts; supplier management; quality, EHS, and regulatory compliance expertise
Technologies
GMP/GAMP standards; Front End Engineering; commissioning and qualification protocols
Responsibilities
Develop equipment specifications and technical requirements based on user needs and regulations; conduct technical studies and budget estimation for CAPEX projects; manage the execution of equipment installation, construction, and commissioning; coordinate with internal departments, SMEs, and external vendors; support troubleshooting, CAPA, and continuous improvement post-installation
Seniority
Manager, hands-on IC
