Validation Specialist- III

Company 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

• QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. 

• It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets their needs and intended use. 

• This position is responsible for qualifying analytical and microbiological testing instrumentation for the company. 

• These are some of the responsibilities: 

• Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems. 

• Coordinate the purchase, commissioning and introduction to service of new equipment.

• Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. 

• Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation. 

• Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment. 

Skills:

• Demonstrated scientific technical writing ability. 

• Knowledge of USP 1058 and GAMP methodology. 

• Knowledge of 21CFR Parts 11, 210, 211, 600 and 610. 

• Experience with Empower and LIMS systems. 

• Previous hands on experience performing laboratory equipment qualification. 

• Proficient in Outlook and Microsoft Word and Excel and lab based data management systems. 

• Ability to gown and enter laboratory 

• May require off shift work to support activities 

• Ability to gown and enter laboratory 

• May require off shift work to support activities 

Qualifications

Education: 

• Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or 
  
• Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience 
•  Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA.

Additional Information

For more information, please contact:

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

 Artech Information Systems LLC

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

Office: 973.967.3348 | Fax: 973.998.2599

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