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Validation Engineer

3 months ago

Wichita, Kansas, United States Fagron Sterile Services Full time
About the job

The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems.

Responsibilities:
  • Prepare, execute and summarize validation protocols and reports.
  • Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.
  • Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.
  • Working knowledge of PC and PLC base control systems software and hardware.
  • Working knowledge of FDA and cGMP guidelines as related to CVQ.
  • Experience validating and qualifying, but not limited to Utilities, Distillate Systems, Syringe, Vial and Eye Dropper Filling Machines, Autoclaves, Glassware and Vial Washers, Stability Chambers Drug Product Storage and Cleanrooms.
  • Experience with PV and Stability studies.
Set yourself apart

Profile/Experiences:
  • BS degree in Mechanical, Industrial, Automation, or Chemical Engineering. and/or equivalent experience in pharmaceutical related discipline.
  • 3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.
  • Experience participating in regulatory inspections and explaining/defending work.
  • General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.
  • Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.
  • Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.
  • Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).
  • Knowledge of GMP including international regulations.
  • Knowledge of applicable parts of 21 CFR Part 210, and 211 regulations and guidance.
  • Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
  • Good verbal and written communication skills
What's on offer?

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.