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.

• Plan, author, and execute validation deliverables — including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports — across assigned systems
• Support CSV activities spanning lab instruments (HPLC, GC, spectrophotometers, balances, and similar), engineering and manufacturing equipment, and enterprise systems such as Caliber LIMS, SAP, and BMRAM
• Partner with system owners, QA, and IT to keep systems in a validated state through change control and periodic review
• Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
• Support audits, inspections, CAPA investigations, and deviations involving computerized systems
• Collaborate with senior validation leads and subject matter experts to drive consistent validation practices across sites

• Bachelor's degree in Life Sciences, Engineering, or IT — or equivalent laboratory experience in a life sciences environment
• Minimum 5 years of CSV experience in a GxP-regulated environment
• Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
• Hands-on experience authoring and executing IQ/OQ/PQ protocols

• Familiarity with GAMP 5 principles and risk-based validation approaches
• Exposure to Caliber LIMS
• Exposure to SAP (QM, MM, PP) in a GxP context
• Experience with BMRAM or an equivalent CMMS/calibration system
• Prior experience serving as a liaison across IT, Quality, Lab, and Manufacturing teams