Computer System Validation (CSV) Engineer

Job TypeFull-timeDescriptionPosition Type: Full-time Employee (FTE)Location: Piscataway, NJ (onsite - physical presence required)Reports To: Sr. Director of ITWork Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the futurePosition SummaryWe are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.Essential Duties & ResponsibilitiesPlan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systemsSupport CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAMPartner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic reviewExecute risk assessments and data integrity assessments aligned with ALCOA+ principlesSupport audits, inspections, CAPA investigations, and deviations related to computerized systemsCollaborating with senior validation leads and SMEs to drive consistent practices across sitesRequirementsPosition Requirements and QualificationsBachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environmentMinimum 5 years of CSV experience in a GxP-regulated environmentWorking knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidanceHands-on experience authoring and executing IQ/OQ/PQ protocolsExperience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)ExperienceMinimum 5 years of CSV experience in a GxP-regulated environmentWorking knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidanceHands-on experience authoring and executing IQ/OQ/PQ protocolsExperience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)Specialized Knowledge And SkillsFamiliarity with GAMP 5 principles and risk-based validationExposure to Caliber LIMSExposure to SAP (QM, MM, PP) in a GxP contextExperience with BMRAM or equivalent CMMS/calibration systemsPrior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teamsWork Environment & Physical DemandsThis is an on-site positionMust be able to work extended hours or weekend hours, as may be required.NoiseNo extraordinary noise levels.Standing/LiftingVery unlikely, but can be able to lift at least 20 lbs.VisualNo extraordinary requirements.StressHigh-paced demanding environment to meet ambitious project goals.TravelModerate domestic travel may be required.