Cqv Engineer

Takeda

Grange Castle, Ireland
Base: competitive salary; bonus/equity: performanc...
Commissioning and qualification activities
Validation of process equipment and utilities
Regulatory audit experience
The CQV Engineer will support commissioning, qualification and validation of all process equipment, facilities and utilities on site while ensuring compliance with industry regulations

Job Summary

  • The CQV Engineer will support commissioning, qualification and validation of all process equipment, facilities and utilities on site while ensuring compliance with industry regulations.
  • Takeda offers a competitive salary including performance-based bonuses, comprehensive insurance, retirement plan contributions, and various wellbeing and family-friendly policies.
  • The company fosters an inclusive and collaborative workplace committed to delivering better health and a brighter future globally.

Matching Summary

The CQV Engineer will support commissioning, qualification and validation of all process equipment, facilities and utilities on site while ensuring compliance with industry regulations.

Salary

Base: Competitive Salary; Bonus/Equity: Performance-based bonuses; Benefits: Comprehensive insurance, retirement plan, flexible benefits

Skills & Requirements

Must-have

  • Commissioning and qualification activities
  • Validation of process equipment and utilities
  • Regulatory audit experience
  • Equipment re-qualification management
  • Pharmaceutical facility validation
  • Vendor document review
  • CAPEX validation support

Nice-to-have

  • Experience with Kneat Validation Software
  • Training material preparation and delivery
  • Environmental Health and Safety compliance
  • Fostering safety culture
  • Coaching and mentoring opportunities

Key Requirements

  • 3rd level Engineering or Science Degree
  • At least three years validation experience in pharmaceutical setting
  • Experience with regulatory audits related to equipment qualification
  • Knowledge of FDA 21 CFR Part 11 and CSV
  • Experience with mechanical installations in API and capsule manufacturing
  • Knowledge of ISPE, ASME, ASTM engineering practices

Work Rights

Not specified

Tailored Resume

Cover Letter