Cqv Engineer

Takeda

Grange Castle, Ireland
Competitive salary; including performance-based bo...
Cqv activities for fue systems
Equipment re-qualification requirements
Validation requirements pharmaceutical manufacturing
The CQV Engineer reports to the Engineering Services Manager and will participate in all Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment (FUE) systems on site, along with equipment re-qualification requirements

Job Summary

  • The CQV Engineer reports to the Engineering Services Manager and will participate in all Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment (FUE) systems on site, along with equipment re-qualification requirements.
  • We are looking for a deep experience of the validation requirements associated with a pharmaceutical manufacturing facility.
  • Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

Matching Summary

The CQV Engineer reports to the Engineering Services Manager and will participate in all Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment (FUE) systems on site, along with equipment re-qualification requirements.

Salary

Competitive Salary; Including performance-based bonuses; Employer contributions to your retirement plan

Skills & Requirements

Must-have

  • CQV activities for FUE systems
  • equipment re-qualification requirements
  • validation requirements pharmaceutical manufacturing
  • review vendor documents
  • execute validation plans protocols reports
  • ensure compliance industry regulations

Nice-to-have

  • foster ethos culture safety awareness
  • preparation delivery training material
  • support department performance
  • foster inclusive collaborative workplace

Key Requirements

  • 3rd level Engineering or Science Degree
  • At least three years validation experience
  • experience with computer system validation
  • experience mechanical installations/modifications tests
  • Knowledge of CSV FDA 21 CFR Part 11
  • Knowledge of Engineering practices ISPE ASME ASTM
  • Experience writing validation plans
  • Experience in Kneat Validation Software desirable

Work Rights

Not specified

Tailored Resume

Cover Letter