Johnson & Johnson Careers

【Janssen】Validation Engineer

Fuji, Japan
Validation


Job Description

Requisition ID: 1805666440W

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
Standards deployment, PAT, technology

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

Comply with following regulation.

・GMP

・Narcotics and Psychotropic Control Law

・The Pharmaceutical Affairs Law

・Janssen global standard related EH&S.

職務の詳細ESSENTIAL DUTIES:

Accomplishment the following duties.
  1. NPI / LCM - Technology transfer coordination at site
・Implementation of risk assessment.
・Creating user requirement specification for new product.
  1. Validation execution (Process and Cleaning Validation)

・Planning, reporting and Implementation for  process validation and cleaning validation.

・management the schedule of validation  implementation .

  1. Process improvements execution

・Forwarding  automation for equipment  followed lean in consideration of production efficiency and quality.

  1. Standards deployment, PAT, technology
・Implementation of gap analysis and improvement  followed  global standard.


Qualifications

教育/経験EDUCATION/EXPERIENCE:(Essential)

・English communication(basic)
・Knowledge of GMP including validation and qualification.
・Knowledge of product  process.
教育/経験EDUCATION/EXPERIENCE:(Desirable)
・Expertise on pharmaceutical manufacturing processes and products.

・knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially

・English communication(Fluent)
・knowledge of NPI / LCM
技能COGNITIVE SKILLS:

・Not specified

資格及び技能EQUIPMENT, TOOLS, MACHIERY AND MATERIALS:

・Not specified

その他 OTHER REQUIREMENTS:

LANGUAGES:

・Fluent in written and spoken Local Language (ideal not a must) 

・Must = write and speak English(Basic).

PHYSICAL REQUIREMENTS/WORKING CONDITIONS: 

・Document mgmt. systems suchs as ERIS DocSpace,

・Webtraining / Compliance Wire
・MS Office applications
・Trackwise
・Webtraining / Compliance Wire


Primary Location
Japan-Shizuoka-Ken-Fuji
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Validation
Requisition ID
1805666440W