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Validation Specialist II
Validation Specialist IIArtech Information System LLC • Canton, MS, US
Validation Specialist II

Validation Specialist II

Artech Information System LLC • Canton, MS, US
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Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting / financial flexibility by offering contingent labor as a variable cost.

Job Description

The consultant will use his / her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer system validation (CSV) methodologies and principles to perform CSV on a variety of laboratory systems in the QC department at the Canton site.

The successful candidate must be an independent performer with significant experience in a cGMP environment, and will work with minimal supervision.

Skills

  • At least 2-4 years of Computer System Validation experience in a laboratory environment.
  • Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, DSN, summary report).
  • An excellent understanding of CFR-Part 11 Compliance for Electronic Data Systems.
  • A good understanding of laboratory instruments such as HPLCs, TOC, UV-Spectrophotometers, FT-IRs among others.
  • A good understanding of the Windows OS (XP / Windows7) including file hierarchies, Data Structures, Networking and VBS or other basic scripting languages.
  • A basic understanding of Microsoft SQL is a plus.

Qualifications

BS in Chemistry / Biology / Computer Science or a related area with significant experience in laboratory instrumentation in a cGMP environment.

J-18808-Ljbffr

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Validation Specialist • Canton, MS, US

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