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Computer System Validation Specialist
2 months ago
Exciting Career Opportunity at Ellab - Validation & Monitoring Solutions
We are looking for a Computer System Validation/Data Integrity Specialist to become a vital part of our dynamic organization and engage in a rewarding professional journey.
As a leader in our industry, Ellab is dedicated to offering exceptional benefits that distinguish us from the competition. Here’s what you can expect:
Time Off:
- Begin your career with 2 weeks of vacation, increasing to 3 weeks after 5 years and 4 weeks after 10 years.
- Prioritize your health with 2 weeks of sick leave.
- Enjoy 10 Company Holidays throughout the year.
- Participate in a refreshing 1-week winter shutdown.
Financial Security:
- Enhance your future with a 401(k) plan featuring a $1 for $1 match up to 4%.
Health and Family Benefits:
- Experience peace of mind with fully covered family medical insurance.
- Access dental, vision, life, and disability insurance options.
- Benefit from 6 weeks of parental leave.
Key Responsibilities:
- Develop, secure approvals for, and implement validation documentation for computerized systems and associated infrastructure. This includes Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring compliance with regulatory and procedural standards such as 21 CFR Part-11, Annex-11 Data Integrity, and GAMP5.
Required Qualifications:
- Proven experience in Computer System Validation, particularly with DCS, SCADA, and BMS systems like DeltaV, Factory Talk View, Desigo, Unicorn, and Wonderware.
- Experience level of 4-6 years is preferred.
- Familiarity with KNEAT is a plus.
Please note that candidates from recruiting agencies or Corp to Corp agencies will not be considered.