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Computer system Validation Engineer Job
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| Employer Name: ND Global Consulting Services Inc |
SpiderID: 13894355 |
| Location: Wilmington, Ohio |
Date Posted: 11/26/2024 |
| Wage: 100000 |
Category: Biotech |
| Job Code: |
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| Number Of Openings: 1 |
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Job Description:
Computer System Validation Engineer is needed to perform the following duties:
● Develop/Execute Qualification (Commissioning/IOQ/IQ/OQ/PQ), Standard operating procedures (SOP), and specifications.
● Assuring that validation activities are carried out within the regulatory (FDA) requirements as they pertain to 21CFR part 11 in terms of validation, operating procedures, and training to assigned and also coordinate validation activities from other departments. Train other validation personnel as a new joiner to the team.
● Working with Quality assurance (QA) to ensure compliance with regulation.
● Documentation includes, but not limited to: Life cycle documents created and manage Risk Assessments, Validation Plans, Design Specifications, User Requirements, Functional Requirements, IOQ, IQ/OQ/PQ Protocols, Requirements Traceability Matrices, Summary Reports, change control, CAPA, Exceptional condition and risk assessments.
● Development including Create, review and modify of Standard operating procedures (SOPs), Maintenance Calibration Procedures, and other Instrument/ equipment support documentation.
● Performing Automation Testing to improve Software Quality and create good quality test data.W
● Code Coverage handled with deep checks making sure third-party accessibility is authenticated as per enterprise level.
● Automation Test Scripts are executed continuously, and results are posted in Quality Hub.
● Developing Delta V test procedures by gathering the information from the customer to match with requirements and create (Recipes) for the operation qualification of Process Equipment and Batch controlling with Syncade.
● Code Repositories are stored and maintained in Cloud Databases, which helps in Data Management.
● Review the project plan and project schedule.
● Meeting with stakeholders, Share the test plan with project stakeholders and getting their feedback and approvals.
● Escalating any critical / showstopper issues to the project stakeholders.
● Perform Load / Functional Testing.
Job Requirements:
Bachelor's Degree is required in Computer Science or Computer Engineering or Computer Information Systems.
Job Criteria:
Start Date: 12/02/2024
Position Type: Full-Time Permanent
Years of Experience Required: 2
Education Required: Masters
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Rashmi Kumari |
Company Type: |
| Company: ND Global Consulting Services Inc |
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| City: Metuchen |
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| State: Florida |
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| Zip: 08840 |
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Web Site: https://www.ndgcs.com
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