CQV Engineer

4 weeks ago

Kalamazoo, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Improve the compliance footprint for the automation team by implementing continuous improvement practices for them to follow. These relate to regulatory, corporate and site policies and practices.
  • Update Data Integrity Assessments and route them through change control.
  • Review and route for FS, FAT, and SAT document approval.
  • uthor and route VTP documents for authorization and execution.
  • uthor and route SARR documents for authorization.
  • Monitor the document authorization process, ensuring completion in line with deadlines.
Requirements:
  • BSc or MSc in Engineering (or equivalent experience).
  • 3-5 years of automation C&V experience.
  • utomation design experience in a pharmaceutical environment.
  • Experience working in a team environment.
  • Excellent English reading, writing, speaking and communication skills required.
  • Professional Engineer license (preferred not required).
  • Experience with the KNEAT electronic document system (preferred not required).