Validation Engineer

2 weeks ago


Sterling, United States Premier Life Sciences LLC Full time

Not for C2C Candidates Please


Role: All Validation Engineer (V&V, CQV, CSV, Equipment, Process)

Location: Country Wide USA

Duration: 12+ months + extensions

Visa{ USC, GC, H4 OPT CPT


Job Description:

  • Process and equipment qualification (IQ/OQ/PQ).
  • Development of test methods for Design V&V, Process Validation, and Production
  • Validation of test methods
  • Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
  • Authoring/releasing of new test methods and editing/redlining of old test methods


The education/experience I am looking for is as follows:

  • This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
  • Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
  • Clean room environment experience
  • Manufacturing Engineering and automation experience.
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred.
  • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
  • Strong organizational skills, detail oriented.
  • Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
  • Ability to work to a deadline and to handle multiple tasks simultaneously.
  • Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.


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