Sr. Validation Engineer Ii

Takeda UK

Thousand Oaks, CA, USA
Base: $116,000.00 - $182,270.00; bonus/equity: not...
Validation maintenance of equipment, systems, facilities, and utilities
Cycle development (cd), design qualification, commissioning and qualification
Performance qualification (pq) / cleaning validation (cv)
Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance

Job Summary

  • Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance.
  • 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.
  • Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, computerized systems, utilities, facility, and computerized systems.

Matching Summary

Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance.

Salary

Base: $116,000.00 - $182,270.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), PTO, etc.

Skills & Requirements

Must-have

  • Validation maintenance of equipment, systems, facilities, and utilities
  • Cycle Development (CD), Design Qualification, Commissioning and Qualification
  • Performance Qualification (PQ) / Cleaning Validation (CV)
  • Project manager for validation deliverables
  • Subject matter expert (SME) on cross-functional teams
  • State of inspection readiness
  • cGMP and applicable regulations

Nice-to-have

  • Continuous improvement focus
  • Experience with LIMS, MES, ERP, SCADA, or DCS
  • Problem-solving mindset
  • Foster continuous learning environment

Key Requirements

  • BS engineering with 10+ years experience
  • Advanced knowledge of equipment, systems, facilities, utilities
  • Advanced knowledge of commissioning and qualification
  • Technical expertise to define validation approaches
  • Ability to work independently or in teams

Work Rights

Not specified

Tailored Resume

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