Validation Engineer

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Sujay Dinari

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May 3, 2019, 11:21:15 AM5/3/19
to Sujay Dinari, ha...@dynamic-enterprise.net, Jos...@dynamic-enterprise.net

Hi,

Hope you are doing great!

This is Sujay from Dynamic Enterprise Solutions. We have urgent requirement with one of our client’s, please review below job description and let me know your interest

Title: Validation Engineer

Location: North Chicago, IL

Duration:  12 Months

Locals Preferred

DESCRIPTION:

5 to 10 YEARS OF EXPERIENCE IN THE FOLLOWING: RESPONSIBILITIES: The candidate is responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11. Lead or participate in various reviews, risk analyses and other software quality assurance activities. Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities. Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards. The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources. Good with verbal and written communication skills. 

REQUIRED:
Minimum Bachelors degree, background in software engineering or software quality assurance. Hands-on professional with experience in the software lifecycle (SLC) 
Must be able to work 50 weeks out of the year, excluding Client holidays. 

INTAKE CALL NOTES: 
Daily job responsibilities they vary but overall: 
• Review and approve computerized system deliverables for compliance with this process and quality standards 
• Ensure that deliverables for the GxP are compliant with applicable policies, processes, and procedures 
• Provide subject matter expertise on GxP regulatory requirements 

Preferred skill-sets: 
Prefers SAP experience 

Required skill-sets: 
• Experience working with software lifecycle deliverables and ability to incorporate updates to meet the needs of the business and project teams; 
• Effective time management and ability to adjust workload to meet customer needs; 
• Excellent interpersonal skills with the ability to work collaboratively with multiple project teams of differing backgrounds 

Thanks & Regards

Sujay Dinari
Technical Recruiter
Dynamic Enterprise Solutions Inc

1801 Hicks Rd, unit A

Rolling Meadows, IL -60008

Phone: (847) 719-7905
Email:
su...@dynamic-enterprise.net

URL: http// www.dynamic-enterprise.net

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