QMS & SAP Validation Analyst (Contract)

Job TypeContractDescriptionPosition 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 ITRate: $65–$75/hour, not overtime eligibleWork Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the futurePosition SummaryWe 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 & ResponsibilitiesSupport validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reportsSupport SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversightContribute to risk assessments, data integrity assessments, and change control documentationLiaise with QA, IT, business process owners, and external SAP implementation partnersSupport periodic review and maintenance of validated state for assigned systemsAssist in audit and inspection readiness for MasterControl and SAPRequirementsPosition Requirements and QualificationsBachelor'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 experiencePrior exposure to CSV activities in a GxP-regulated environmentWorking understanding of 21 CFR Part 11, EU Annex 11, and EMA guidanceExperience authoring or executing validation protocolsExperienceExposure to MasterControl QMS (validation, administration, or end-user)Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environmentFamiliarity with GAMP 5 principlesExperience with ALCOA+ data integrity principlesPrior experience supporting enterprise system implementations in pharma, biotech, or medical deviceSpecialized Knowledge and Skills:Familiarity with GAMP 5 principles and risk-based validationExposure to Caliber LIMSExposure to SAP (QM, MM, PP) in a GxP contextPrior 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.