Junior Validation Specialist
2 weeks ago
We are seeking a highly skilled Junior CSV Engineer to join our team. This role involves developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.
The ideal candidate will have a degree in Computer Science or Engineering and 1-3 years of experience with computer systems validation. Additionally, they should have 1 year of experience working in a GMP environment, along with experience in Data Integrity, GAMP, and 483 compliance consent decree. A strong understanding of biotech and pharma is preferred, as well as experience with MES Delta V PI and other major systems such as Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, and Wonderware.
Key Responsibilities
- Develop and execute protocols and test scripts
- Identify gaps and consult on and direct plans for resolution
- Write GxP computer validation and 21 CFR Part 11 related documentation
Requirements
- BS in Computer Science or Engineering field or equivalent experience
- 1-3 years experience with Computer systems validation
- 1 years experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483 compliance consent decree
- Experience in biotech and pharma preferred
- Experience with MES Delta V PI is a plus
Benefits
This is an exciting opportunity to work with a leading organization that values collaboration and innovation. Our company culture prioritizes employee growth and development, and we offer a dynamic work environment that encourages creativity and teamwork.
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