Validation Specialist II

Artech Information System LLC; Canton (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading IT staffing firm in Canton seeks a consultant for Computer System Validation (CSV) in the QC department. The successful candidate will apply their cGMP knowledge and experience to validate a variety of laboratory systems effectively. Candidates should have 2-4 years of CSV experience, along with an understanding of CFR-Part 11 Compliance and laboratory instruments. This position demands minimal supervision, making independent performance essential.

Qualifications

• 2-4 years of Computer System Validation experience in a laboratory environment.
• Experience writing, reviewing and executing computer validation documentation.
• Understanding of laboratory instruments like HPLC, TOC, UV-Spectrophotometers, FT-IR.
• Experience in a cGMP environment.

Responsibilities

• Perform computer system validation on various laboratory systems.
• Work with minimal supervision in a cGMP environment.

Skills

Computer System Validation experience

CFR-Part 11 Compliance

Understanding of laboratory instruments

Windows OS knowledge

Basic understanding of Microsoft SQL

Education

BS in Chemistry/Biology/Computer Science or related area

Job description

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 HPLC's, TOC, UV-Spectrophotometers, FT-IR's 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.

Additional Information

Best Regards,

Akriti Gupta

Associate Recruiter(Scientific & Clinical Division)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3409 | Fax: [phone]

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