Computer System Validation (CSV) Engineer

Job Title: Computer System Validation (CSV) Engineer Location: Boston, MA (Hybrid) Duration: 12+ Months Contract Position Summary We are seeking an experienced Computer System Validation (CSV) Engineer to support validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical/biotechnology manufacturing environment. The ideal candidate will have strong experience in FDA-regulated industries and hands-on expertise with validation lifecycle activities for manufacturing, laboratory, and quality systems. Key Responsibilities • Perform Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, GAMP 5, and cGMP regulations. • Develop and execute validation documentation including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Summary Reports. • Support qualification and validation of computerized systems used in manufacturing, quality, laboratory, and automation environments. • Review and approve system lifecycle documentation, SOPs, change controls, deviations, and CAPAs. • Collaborate with Quality Assurance, IT, Engineering, Automation, Manufacturing, and Validation teams to ensure compliance and project execution. • Support data integrity assessments and ensure systems comply with ALCOA+ principles. • Participate in risk assessments and periodic reviews for validated systems. • Support implementation and validation of systems such as LIMS, MES, SCADA, PLC, ERP, CMMS, and electronic quality management systems. • Ensure validation deliverables are completed within project timelines. • Provide audit support during internal, client, and regulatory inspections. Required Qualifications • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. • 5+ years of CSV experience within pharmaceutical, biotech, or medical device industries. • Strong understanding of cGMP, FDA regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines. • Experience with validation of GxP computerized systems and infrastructure qualification. • Hands-on experience with validation documentation and execution. • Knowledge of change control, deviation management, CAPA, and risk management processes. • Excellent communication and cross-functional collaboration skills. Preferred Skills • Experience with systems such as TrackWise, Veeva, SAP, LabWare LIMS, DeltaV, Emerson Syncade, MasterControl, or Siemens platforms. • Prior experience supporting manufacturing facilities, laboratories, or automation systems in pharma/biotech environments. • Experience with cloud-based systems validation and data integrity initiatives is preferred. Work Environment • Pharmaceutical/biotech GMP-regulated environment. • Hybrid or onsite role based in the Greater Boston/Cambridge, MA area. • Ability to support occasional off-hours validation activities if required.