Validation Engineer/ Specialist

Johns Creek , United States
full-time

AI overview

Lead the validation activities for critical medical device projects, ensuring compliance and efficiency in validating autoclaves and temperature controllers within a regulated environment.

The Validation Engineer/ Specialist will be responsible of all validation activities for the assigned project. This project include the validation of multiple autoclaves and Temperature controllers.  Validation Scope may include: Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, C&Q activities, among others. 

 

  • Bachelor degree in Engineering or Science 
  • 5 to 10  years of experience required in the medical device, biotechnology or pharmaceutical industry (liquid dosage a PLUS).
  • MUST have experience validating autoclaves
  • Experience with Validation Life Cycle (Process, Packaging and Cleaning).
  • Experience and knowledge in regulations, including GMP.
  • Experience developing and conducting efficient processes to meet production demands.
  • Excellent technical writing and verbal communication skills are required.
  • Excellent detail oriented individual who can identify milestones.
  • Great interpersonal and communications skills.
  • Able to interact with all areas and clients.
  • Proficiency utilizing  MS Office Suite (Word, Excel and PowerPoint) is required.
  • Available to work extended hours, holidays if require. 
  • Must be available to travel and work non-standard shifts if necessary.
  • Only candidates who qualifies with all requirements will be evaluate.
  • Bilingual (Spanish & English) a plus but not necessary.

 

Validation and Engineering Group, USA  Inc. is an Equal Employment Opportunity employer.

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