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Validation Specialist
Ref No.: 18-39581
Location: Franklin Lakes, New Jersey
Position Type:Contract
Shift:First
Job Category:Engineering
Benefits:Medical Insurance
Hiring a Contract Validation Speciaist 
Duration: 1 year contract
Client Location:  Franklin Lakes, NJ
Work Schedule:  Monday - Friday / 40 Hours Weekly
Pay Rate:  $41 Hourly 


Reporting to the Engineering Manager, the associate plans and performs software validations on off-the-shelf laboratory equipment. These are equipment with commercially available software running on standard hardware components. Example: Instron testing machine

RESPONSIBILITIES:

Write software validation protocols for commercial-off-the-shelf laboratory equipment. This includes:
• Writing User Requirement Specifications (URS)
o Determine what the equipment needs to do based on Company’s intended use
• Creating Trace Matrix
o Trace how each URS is met by test cases and other validation activities
• Writing and Executing Test Cases
o Design simple test scripts based on process flows, administration tasks, and equipment functions
o Oversee the execution of test scripts by Company personnel
o Ensure test script execution results are documented

EDUCATION: College degree in a technical field.

EXPERIENCE: Minimum 3 years of industry experience

SPECIAL SKILLS

Mandatory:
• Equipment validation experience in a regulated industry (e.g. IQ/OQ/PQ in medical device company). Specifically, able to write equipment validation protocols and reports.
• Ability to mentally break down complex processes into simpler components
• Superior technical writing skills
• High computer literacy

Highly Desired:
• Direct experience in planning or executing software validation of off-the-shelf computerized equipment
• Proficiency in operating computerized laboratory equipment such as Instron testing machines, FTIR, blood chemistry analyzers
To Apply for immediate consideration please send resume to Michael Estaris at Michael.Estaris@onboardusa.com and reference job #18-39581 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
**Candidates must complete background and drug screenings before starting any assignment.
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.