Sr. Process engineer, Pharmaceuticals, Shiga , 13.5M
800万円 - 1350万円
Working with Professional team in the market
rewarding and Challenging task will be provided
- The company's core competencies are in the fields of health care and agriculture.
- Company has a diverse portfolio of products with businesses in pharmaceuticals, consumer health and crop science.
- Support of Current GMP(cGMP) production for market supply
- Maintain CMC manufacturing records and documentation (authoring and reviewing technical reports,protocols, technology transfer documents, CMC sections in regulatory filings, TRDs)
- Supporting technology transfer and process development to cGMP manufacturing, site transfers ofcommercial manufacturing processes as required
- Providing ongoing technical support for change control, deviation investigations and CAPAmanagement as required during development and commercial manufacturing of products
- Ensure transfer of knowledge within the global production network: data evaluation and sharingbetween sites; exchange of process optimization opportunities and regular
- Provide process and product expertise and solutions in global trouble shootings
- Great experience in Chemical, Biomedical, Industrial Engineering etc. plus Production and/or Engineering experience in the Pharmaceutical industry
- Good experience with cGMP, international guidelines and regulations with knowledge of systems and standard documentation required in the pharmaceutical industry.
- Experience in support of launch, tech transfer, and/or sustaining cGMP commercial drug product manufacturing process operations in bio-pharmaceuticals
- Experience / technical knowledge with drug product manufacturing required (i.e. formulation,aseptic filling)
- Knowledge of process validation requirements and cGMP regulatory guidelines
- Fluent in Japanese and English
Annual income up to about 13.5 million yen