Validation Engineer Job
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Employer: ND Global Consulting Services Inc
SpiderID: 14011910
Location: Raritan, New Jersey
Posted: 6/12/2025
Wage: 91894
Priority Review Date: 9/10/2025
Job Code / NOC / SOC:
Category: Biotech
Job Description:
A Validation Engineer is needed to perform the following duties:
· · Develop and execute validation protocols (IQ/OQ/PQ), including URS, traceability matrix, and final reports.
· Manage project plans for equipment qualification with defined scope, timeline, and risk management
· Perform risk assessments, change controls, and deviation investigations
· Communicate with vendors during IOPQ execution to troubleshoot issues and resolve nonconformances
· Coordinate FAT/SAT, system commissioning, and walkthroughs with vendor and internal teams
· Review and maintain work orders related to lab and manufacturing equipment; follow up on service actions and equipment status.
· Analyze validation data, summarize test results, and prepare audit-ready documentation
· Ensure compliance with 21 CFR Part 11, EU Annex 11, and internal data integrity policies
· Prepare/review SOPs, perform periodic reviews, and support CAPAs and quality improvement projects
· · Develop and execute validation protocols (IQ/OQ/PQ), including URS, traceability matrix, and final reports.
· Manage project plans for equipment qualification with defined scope, timeline, and risk management
· Perform risk assessments, change controls, and deviation investigations
· Communicate with vendors during IOPQ execution to troubleshoot issues and resolve nonconformances
· Coordinate FAT/SAT, system commissioning, and walkthroughs with vendor and internal teams
· Review and maintain work orders related to lab and manufacturing equipment; follow up on service actions and equipment status.
· Analyze validation data, summarize test results, and prepare audit-ready documentation
· Ensure compliance with 21 CFR Part 11, EU Annex 11, and internal data integrity policies
· Prepare/review SOPs, perform periodic reviews, and support CAPAs and quality improvement projects
Job Requirements:
Bachelor's Degree in Mechanical Engineering
Job Criteria:
Start Date: 10/1/2025
Position Type: Full-Time Permanent
Experience: 2
Education: Bachelors
Travel:
Vacation:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Rashmi Kumari | Type: |
| Company: ND Global Consulting Services Inc | |
| Web Site: https://www.ndgcs.com | |