Validation Specialist II

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