Site Engineering Services Associate Director/ Manager

Takedajobs

Narita, Chiba, Japan
Native level japanese proficiency
Cgmp compliance
Validation strategy development
This position is responsible for executing validation activities at the Narita plant, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes, ensuring continuous cGMP compliance

Job Summary

  • This position is responsible for executing validation activities at the Narita plant, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes, ensuring continuous cGMP compliance.
  • The role involves managing validation personnel and projects within quality, time, and budget constraints, coordinating effectively with various departments including Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control.
  • Takeda offers a comprehensive compensation and benefits package including allowances, annual salary increases, twice-yearly bonuses, and a generous holiday schedule of approximately 123 days per year.

Matching Summary

This position is responsible for executing validation activities at the Narita plant, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes, ensuring continuous cGMP compliance.

Skills & Requirements

Must-have

  • Native level Japanese proficiency
  • cGMP compliance
  • Validation strategy development
  • Cross-functional team coordination
  • Regulatory authority inspection support

Nice-to-have

  • Proactive problem-solving
  • Adaptability to changing environments
  • Commitment to patient well-being

Key Requirements

  • Bachelor's degree in Engineering or Science
  • Experience with FDA and other regulatory authorities
  • Project management experience

Work Rights

Not specified

Tailored Resume

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