[Janssen] Validation Engineer, Manufacturing And Supply Div, Fuji Plant Technical Operations

Description:
職務概要DESCRIPTION:
The regular Engineer is responsible for the following duties.

• NPI / LCM - Technology transfer coordination at site
• Validation execution (Process and Cleaning Validation)
• Process improvements execution
• Standards deployment, PAT, technology
  

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

• 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.
• Narcotics and Psychotropic Control Law – Adhere to narcotics and psychotropic Control Law.
• The Pharmaceutical Affairs Law – Adhere to the Japanese pharmaceutical affairs law
  

職務の詳細ESSENTIAL DUTIES:
Accomplishment of the following duties.

• 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.
• Execute lifecycle strategy as documented per the relevant LCM SOPs.
• Support new product introduction by leading validation and qualification items for the projects he/she owns.
• Review and approve all documents related to validation and qualification(Validation responsible person as per GMP organization chart).
• Create and revise the related SOPs and Validation Master Plan to comply with Japanese GMP requirements and Janssen global requirements.
• Perform risk assessments for changes as part of the change control process from a validation perspective.
• Support the training of other departments in validation.
• 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).
• Support troubleshooting activities in alignment with the validation manager and other relevant departments.
• Connect with regulatory and other quality functions to ensure continuous alignment.
• Build strong relationships with global, regional, and local organizations to enable the execution of validation items and improve
  

Qualifications:
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: