QMS & SAP Validation Analyst (Contract)

Position Type: Contractor / Consultant – FTC (6-9 Months with possible extension) Location: Piscataway, NJ (onsite - physical presence required) – OR – Chicago, IL (onsite - physical presence required) Reports To: Sr. Director of IT Rate: $65–$75/hour, not overtime eligible Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future Position Summary 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. Essential Duties & Responsibilities 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 Position Requirements and Qualifications 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. Visual No extraordinary requirements. Stress High-paced demanding environment to meet ambitious project goals. Travel Moderate domestic travel may be required. #J-18808-Ljbffr