Sr. Validation Engineer Ii

Takeda

Thousand Oaks, CA, USA
Base: $111,800.00 - $175,670.00; bonus/equity: sho...
Cycle development execution
Design qualification
Commissioning and qualification
This position supports operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities

Job Summary

  • This position supports operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities.
  • Lead the execution of CD/PQ/CV/PV/RV activities and act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
  • U.S. Base Salary Range: $111,800.00 - $175,670.00; U.S. based employees may be eligible for short-term and/or long-term incentives; U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

Matching Summary

This position supports operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities.

Salary

Base: $111,800.00 - $175,670.00; Bonus/Equity: Short-term and/or long-term incentives; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits

Skills & Requirements

Must-have

  • Cycle Development execution
  • Design Qualification
  • Commissioning and Qualification
  • Performance Qualification
  • Cleaning Validation
  • Validation Maintenance
  • cGMP and applicable regulations

Nice-to-have

  • Continuous improvement focus
  • Cross-functional partnerships
  • Inspection readiness
  • Problem-solving mindset
  • Collaborative work style

Key Requirements

  • BS engineering with 10+ years experience
  • Experience with LIMS, MES, ERP, SCADA, or DCS desirable
  • Advanced knowledge of equipment, systems, facilities, utilities
  • Advanced knowledge of commissioning and qualification
  • Technical expertise to define validation approaches
  • Basic understanding of data and statistical analysis

Work Rights

Not specified

Tailored Resume

Cover Letter