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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # QMS & SAP Validation Analyst (Contract) - **Company:** Kashiv BioSciences LLC. - **Location:** Piscataway, NJ, United States - **Experience:** Starter - **Salary:** $135,200.0 - $156,000.0 - **Contract:** Temporary to permanent - **Skills:** Data Integrity, Laboratory Information Management Systems, SAP (Applications), SAP Implementation, Test Execution Engine, Iq/oq/pq, Test Scripts, GXP - **Published:** June 4, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=0da56d98ae8daad1 ## About the Role Do you have experience in Test Execution (Quality assurance practices)?, Do you have a Master's degree?, * Bachelor's degree in Life Sciences, Engineering, IT, or a lab-based role in life sciences with 3+ years of relevant experience; OR Master's degree with 1-2 years of relevant experience * Prior exposure to CSV activities in a GxP-regulated environment * Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance * Experience authoring or executing validation protocols Experience: * Exposure to MasterControl QMS (validation, administration, or end-user) * Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment * Familiarity with GAMP 5 principles * Experience with ALCOA+ data integrity principles * Prior experience supporting enterprise system implementations in pharma, biotech, or medical device Specialized Knowledge and Skills: · * Familiarity with GAMP 5 principles and risk-based validation * Exposure to Caliber LIMS * Exposure to SAP (QM, MM, PP) in a GxP context * Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems. Work Environment & Physical Demands:· * This is an on-site position at our Piscataway, NJ location - OR - Chicago, IL location· * Must be able to work extended hours or weekend hours, as may be required. Noise:· * No extraordinary noise levels. Standing/Lifting:· * Very unlikely, but can be able to lift at least 20 lbs. ## Description We are seeking a Validation Analyst to support validation of our Quality Management System (MasterControl) and SAP implementation (QM, Materials Management, Production modules). This role works under the direction of a senior validation lead and partners with Quality, IT, and business functions to deliver validation artifacts in compliance with 21 CFR Part 11, GxP, and EMA expectations., * Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports * Support SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight * Contribute to risk assessments, data integrity assessments, and change control documentation * Liaise with QA, IT, business process owners, and external SAP implementation partners * Support periodic review and maintenance of validated state for assigned systems * Assist in audit and inspection readiness for MasterControl and SAP ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Are Classical Automation Frameworks Dead? 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