Commissioning, Qualification & Validation Engineers

  • Full Time
  • Dublin

We have a number of exciting opportunities for CQV Engineers  with one of our clients on a major Pharmaceutical construction project in the Greater Dublin area.

Role Functions

Primary responsibilities for the Commissioning and Qualifications Engineer include:

  • Commission and Qualify (C&Q) various process and laboratory equipment. 
  • Design and execute process validation studies for the large Scale API processes. 
  • Review and assess change control for API processes to determine impact on validated state. 
  • Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements. 
  • Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects. 
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc. 
Experience, Knowledge & Skills
Requires degree in Mechanical or Chemical Engineering. 

Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.

  • Minimal work direction needed, highly skilled and knowledgeable to the position.
  • Demonstrated leadership with at least 5 years’ experience in a people management role.
  • Competent Performance qualification, CQV or Technical Leader with credentials in delivery excellence in pharmaceutical operations. 
  • Knowledge of Environmental and Safety regulatory/code requirements to Irish, European and International Codes, Standards and Practices related to Equipment and Maintenance.
  • Ability to manage and drive results, tracking KPIs and team performance; ability to engage, develop and equip teams for success in role execution.
  • Strong background in compliance documentation
  • A record in delivering results in a cross functional environment. 

Experience in any of the following areas is highly desirable:

  • Clean Wet Utilities 
  • HVAC Performance Qualification
  • Bio Safety Cabinets Performance Qualification
  • Controlled Temperature Units Performance Qualification) 

Work permit for Ireland essential.

 

To apply for this job email your details to hrdept@kyronit.com