Senior Specialist, Engineering

[Main business]

Examination of manufacturing equipment (formulation (solid formulation), inspection/packaging (solid formulation / sterile formulation), and technical study when introducing new products

Process/cleaning validation planning, coordination, progress management implementation, document creation

Examination of process stabilization and improvement, improvement of manufacturing equipment, and improvement of raw material packaging materials, etc.

Technical support for on-site improvement activities

Change management of processes and equipment

Prototype management and product life cycle management from the aspect of equipment and operation

Technical support related to daily manufacturing such as abnormal deviation and complaint investigation

Communication-related to production technology and new product introduction with the global

Technical support to contractors and technology transfer support to successors

[Other expected roles]

Contribute to continuous operational improvement to supply pharmaceutical products with high quality and low cost in a timely manner.

We will set up information antennas in Japan and overseas, grasp the latest trends in industry and regulations, strive to improve our own skills, and educate our colleagues and other departments (especially inspection and packaging technology).

In solving the problem, we will provide an efficient and effective solution after fully considering GMP, other laws and regulations, our guidelines, etc.

Qualification requirements (required skills, competencies, qualifications, experience, etc.)

[Necessary qualities]

Bachelor / Master of Science, Graduated from National College of Technology

Work experience in product development, manufacturing, and packaging technology for pharmaceuticals, cosmetics, and food products (5-10 years)

Communication skills in Japanese (fluent level) and English (TOEIC 730 points or higher is desirable)

Ability to execute projects in cross-functional teams

Willingness to learn new things and try new jobs

[Desirable qualities]

General knowledge of GMP and related laws and regulations

Ability to collaborate/collaborate with overseas sites and vendors and utilize their expertise

Ability to solve problems by utilizing data and knowledge gained through operation and testing in manufacturing and packaging equipment, and physical and chemical principles