職務概要DESCRIPTION:

The regular Engineer is responsible for the following duties.

1. NPI / LCM - Technology transfer coordination at site

2. Validation execution (Process and Cleaning Validation)

3. Process improvements execution

4. Standards deployment, PAT, technology

法規制の順守に関する責任 REGULATORY COMPLIANCE RESPONSIBILITIES: (If needed)

(1)Good Manufacturing Practices (GMP) - Adhere to cGMP as per Japan authorities and as per Global J& J/JANSSEN Policies. (2)EHS - Adhere to Janssen global standard-related EH& S.

(3)Narcotics and Psychotropic Control Law - Adhere to narcotics and psychotropic Control Law.

(4)The Pharmaceutical Affairs Law - Adhere to the Japanese pharmaceutical affairs law

職務の詳細ESSENTIAL DUTIES:

Accomplishment of the following duties.

1. Support the maintenance and execution of validation and qualification process improvements as per strategy. This should include, but not be limited to: packaging equipment and/or processes, QC equipment, and computer systems.

2. Execute lifecycle strategy as documented per the relevant LCM SOPs.

3. Support new product introduction by leading validation and qualification items for the projects he/she owns.

4. Review and approve all documents related to validation and qualification(Validation responsible person as per GMP organization chart).

5. Create and revise the related SOPs and Validation Master Plan to comply with Japanese GMP requirements and Janssen global requirements.

6. Perform risk assessments for changes as part of the change control process from a validation perspective.

7. Support the training of other departments in validation.

8. Have responsibility for GMP audit by MHLW and Internal and Janssen Global audit related to validation and qualification(Validation responsible as per GMP organization chart and/or owner of one more of the validation processes in the department).

9. Support troubleshooting activities in alignment with the validation manager and other relevant departments.

10. Connect with regulatory and other quality functions to ensure continuous alignment.

11. Build strong relationships with global, regional, and local organizations to enable the execution of validation items and improve教育/経験EDUCATION/EXPERIENCE: (Essential)

•English communication(advanced)

•Knowledge of GMP including validation and qualification.

•Knowledge of the product process.

教育/経験EDUCATION/EXPERIENCE: (Desirable)

•Expertise in pharmaceutical manufacturing processes and products.

•knowledge of Quality and compliance / regulatory requirements (GMP/EH& S) especially

•English communication(Fluent)

•knowledge of NPI / LCM技能COGNITIVE SKILLS: