・検査機・包装ラインの維持保全：期待どおりの生産が安定的に行えるようにするResponsible for the maintenance of inspection and packaging line to continue the operation with good condition.
・生産設備の技術的性能保証（性能適格性確認などのバリデーション業務）、Responsible for the qualification of production equipment.
Responsible for the calibration of production equipment
Responsible for the supervising of vendors working in production area.
Responsible for providing engineering , improvement of manufacturing facilities, systems, and equipment
Trouble shooting of production equipment operation which include inspection machine & packaging machine
Responsible for the periodical maintenance of the inspection & packaging machine
Manage qualification of the production equipment include documentation and supervising vendor
Responsible for documentation about all maintenance work
SME in the area of engineering and maintenance in CAPA
SME in the area of engineering and maintenance in Change Control
Provide technical leadership and support execution of EHS policies & procedure
Knowledge and experience for production or maintenance
Good communication skills with other department / operator etc.
Documentation skills for meeting minutes and technical report
Bachelor or Master for mechanical/electrical engineering
Knowledge of lean method such as 6σ, 5whys, FMEA, RCA, ME2, OEE management, Operator asset care, etc.
Good documentation skills for validation, maintenance record
Experience on working in the pharmaceutical industry