Computer System Validation (CSV) Engineer

We're looking for an experienced CSV Engineer to support validation activities across a wide portfolio of regulated systems — from laboratory instrumentation to manufacturing equipment to enterprise platforms. This role acts as the connective tissue between Quality, IT, Lab, and Manufacturing, keeping systems validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements. This is an onsite role reporting to the Sr. Director of IT, and candidates must be authorized to work in the U.S. without current or future sponsorship.Contract to Hire: $60-$65/hourWhat you'll doPlan, author, and execute validation deliverables — including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports — across assigned systemsSupport CSV activities spanning lab instruments (HPLC, GC, spectrophotometers, balances, and similar), engineering and manufacturing equipment, and enterprise systems such as Caliber LIMS, SAP, and BMRAMPartner with system owners, QA, and IT to keep 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 involving computerized systemsCollaborate with senior validation leads and subject matter experts to drive consistent validation practices across sitesWhat you'll bringBachelor'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 protocolsValidation experience with at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)Nice to haveFamiliarity with GAMP 5 principles and risk-based validation approachesExposure to Caliber LIMSExposure to SAP (QM, MM, PP) in a GxP contextExperience with BMRAM or an equivalent CMMS/calibration systemPrior experience serving as a liaison across IT, Quality, Lab, and Manufacturing teamsBenefits & perksThis is an onsite position in a fast-paced, deadline-driven setting. It may require extended hours or occasional weekend work, and moderate domestic travel. Physical requirements are light