|NuGenesis ELN Validation Engineer|
Location: Morrisville, NC
Type of position: Contract
Duration: 12+ months
* Candidates must hold a Green Card or US Citizenship
Provide validation activities for projects involving Waters NuGenesis system (ELN).
- 8+ years of CSV experience.
- Prior experience validating / writing test scripts for an ELN - Waters NuGenesis.
- Experience in FDA regulated environment with good understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation.
- Conduct computer system validation work, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.
- Develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.
- Strong verbal and written communication skills are essential.