544 computer system validation engineer jobs at 286 companies in United States
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Computer System Validation (CSV) Engineer
Piscataway, New Jersey, United States
OnsiteFull Time
Kashiv BioSciences, LLC: U.S.-based biopharmaceutical developing and manufacturing affordable biosimilars and complex medicines for patients worldwide.
5+ YOEPlan, author, and execute CSV validation across regulated systems; ensure compliance with 21 CFR Part 11, EMA/GxP; collaborate across IT, QA, Lab, and Manufacturing.
SupermicroNASDAQ: SMCI: Total IT solution provider for AI, cloud, storage, and 5G/edge.
3+ YOEBachelor's degree in a relevant engineering or computer field, 3+ years in systems or firmware validation or technical support, BMC/IPMI/Redfish/BIOS expertise, customer support, testing, troubleshooting, and travel readiness.
Celldex TherapeuticsNASDAQ: CLDX: Public U.S. biopharmaceutical developing antibody therapies for patients with severe inflammatory, allergic, autoimmune and other diseases.
8+ YOERequires 8+ years in cGMP/GLP industries, a technical bachelor's degree or equivalent, and validation experience with regulated computer, network, ERP, Veeva, laboratory, and production systems.
21 CFR Part 11, EU GMP, EU GMP Annex 11, GAMP, ERP, Veeva, AI
AMDNASDAQ: AMD: Leader in high-performance computing, graphics, and visualization technologies.
15+ YOEBachelor's or master's degree in electrical or computer engineering and 15+ years of applicable experience. Requires system and silicon debug, validation, architecture, PCIe/CXL, OS, device driver, BIOS, and technical program management expertise.
Commissioning Agents, Inc.: Private professional services firm delivering commissioning, qualification, validation, and operational-readiness consulting to life-sciences and mission-critical clients.
3+ YOEBachelor's degree in computer science, engineering, or related field; 3+ years of computer systems validation experience; GxP, GAMP, FDA, batch systems, Rockwell, and DeltaV expertise; English communication skills.
Manufacturing Execution System (MES), Distributed Control System (DCS), Supervisory Control and Data Acquisition (SCADA), Rockwell PharmaSuite, Rockwell Automation, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, Product Lifecycle Management (PLM), Simatic, iFix, Wonderware, GAMP, S88, S95
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
5+ YOEBachelor's degree required (CS/engineering/sciences preferred); 5+ years CSV experience; 2+ years with controls/automation, MES or Distributed Systems; biotech/pharma/medical device experience; CAPA/deviation and project experience desired.
DeltaV, Manufacturing Execution Systems (MES), GAMP
WiproNYSE: WIT: Global information technology, consulting, and business process services.
3+ YOEBachelor's degree in electrical engineering, computer science, or a related field; 3+ years of embedded systems or firmware experience, with hands-on complex SoC validation, C, Python, firmware automation, and JTAG debugging.
Praxis Precision MedicinesNasdaq: PRAX: Public CNS biopharmaceutical developing precision therapies for people with epilepsy, movement disorders, and other neurological conditions.
Bachelor's degree or equivalent experience, significant regulated-industry experience, and strong Computer System Validation, Computer Software Assurance, quality systems, data integrity, GxP, GAMP 5, and risk-based validation expertise.
Abeona TherapeuticsNasdaq Capital Market: ABEO: Commercial-stage biopharmaceutical developing cell and gene therapies for patients with serious and rare diseases.
3+ YOE3–5+ years CSV in biotech/pharma; Bachelor's in Life Sciences/Computer Science/Engineering; knowledge of FDA regulations, GAMP 5, data integrity; experience validating GxP systems; strong communication.
7+ YOEBachelor's degree in computer engineering or a relevant science field, 7+ years in QA and compliance systems, 5+ years in computer systems validation, and experience with regulated systems and quality management.
Bristol Myers SquibbNYSE: BMY: Transforming patients' lives through science.
Bachelor’s degree in engineering, science, IT, or related discipline and 3–5 years of compliance and computer systems validation experience, preferably in regulated life sciences manufacturing.
GAMP, ISO 9001, Lean Six Sigma, OPEX, Quality Management System, Service Level Agreements (SLA), Computerized System Validation (CSV), CAPA
FordNYSE: F: Global automotive manufacturer of cars, trucks, and mobility solutions.
5+ YOEBachelor's degree in electrical or computer engineering, 5+ years electrical hardware design and low-voltage validation experience, 3+ years WCCA, power electronics development, testing, diagnostics, and automotive systems knowledge.
Bristol Myers SquibbNYSE: BMY: Transforming patients' lives through science.
3+ YOEBachelor's degree in engineering, science, IT, or related discipline and 3–5 years of compliance and computer system validation experience. Requires regulated manufacturing, risk, audit, deviation, and change management expertise.
21 CFR Part 11, 21 CFR Parts 210/211, GAMP, ISO 9001, Quality Management System, CAPA, Lean Six Sigma, OPEX, Service Level Agreements (SLA)
Fresenius Kabi: Global healthcare specializing in medicines and medical technologies.
1+ YOEBachelor's degree in science or engineering, 1+ year related experience in a cGMP facility, validation protocol experience, cGMP and aseptic technique knowledge, technical writing, communication, and project skills.
MES, Electronic Batch Records (EBR), historian, QMIB, LAB-X, OEE, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft Access
FordNYSE: F: Global automotive manufacturer of cars, trucks, and mobility solutions.
5+ YOEBachelor's degree in electrical or computer engineering, 5+ years of electrical hardware design and low-voltage validation experience, and 3+ years of WCCA. Power electronics, EV architecture, testing, diagnostics, and cross-functional skills required.
Worst Case Circuit Analysis (WCCA), Design For Six Sigma (DFSS), FA report, 8D documentation
Zoox: Autonomous mobility developing a fully electric robotaxi fleet.
5+ YOEBS in Electrical/Computer/Systems Engineering, 5+ years V&V experience for safety‑critical systems, HIL and vehicle testing experience, Python proficiency, statistics knowledge, and expertise in safety and diagnostics.
Principal System Validation Engineer (AI Fabric Switches)
San Jose, California, United States
$237k-$250k/yrOnsiteFull Time
Astera LabsNASDAQ: ALAB: Provider of connectivity solutions for AI data centers.
12+ YOEBachelor's in Electrical or Computer Engineering required (Master's preferred), ≥12 years experience with SoC/silicon for server/storage/networking, hands-on validation/debug of high-speed protocols, Python automation, and lab equipment experience.
Empower Pharmacy: Private U.S. 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving patients, providers, and pharmacies.
3+ YOEBS in engineering or scientific field required; 3+ years validation experience in regulated manufacturing preferred; expertise in CQV, equipment/process/computer system validation, cGMP/GAMP/21 CFR Part 11; strong project, analytical, and communication skills.
AI-enabled analytics tools, validation software, quality management systems, Microsoft Office, digital documentation platforms
E Tech Group: Industrial automation and control systems integrator serving manufacturers and other industrial clients across North America.
10+ YOEBachelor's degree in a related discipline and 10+ years of regulated-environment experience in controls, automation, computerized systems, quality, validation, documentation, commissioning, qualification, or lifecycle compliance.
GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, System Development Life Cycle (SDLC), IT/OT, AI
Renesas ElectronicsTokyo Stock Exchange: 6723: Global provider of embedded semiconductor and system solutions.
5+ YOEBachelor’s or master’s degree in electronics engineering, computer science, or computer engineering; 5–7 years of embedded software experience; proficiency in C/C++, embedded C, testing, and real-time systems.