557 computer systems validation engineer jobs at 289 companies in United States
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Computer Systems Validation Engineer
Boston or Rockville or Frederick
$75k-$106k/yrOnsiteFull Time
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
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
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)
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
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
Lead Computer Systems Validation (CSV) Engineer (W)
The Woodlands, Texas, United States
OnsiteFull Time
Cellipont Bioservices: Cellipont Bioservices is a privately held cell therapy CDMO developing and manufacturing therapies for biopharmaceutical companies.
6+ YOEBachelor's in engineering/computer science/life sciences, 6+ years in regulated biopharma/GMP environment, CSV and data integrity expertise (21 CFR Part 11, EU Annex 11), risk-based validation, Smartsheet and Excel experience, mentorship and cross-functional collaboration skills.
SupermicroNASDAQ: SMCI: Total IT solution provider for AI, cloud, storage, and 5G/edge.
8+ YOEBachelor's degree in a related engineering or computer field and 8+ years in systems or firmware validation or technical support. Requires BMC, IPMI, Redfish, BIOS, troubleshooting, testing, and customer support expertise.
Microchip TechnologyNASDAQ: MCHP: A leading provider of smart, connected, and secure embedded control solutions.
5+ YOERequires 5+ years of silicon or SoC validation experience, C/C++ and Python or Tcl, high-speed lab equipment, system-level debugging, and a Computer/Electrical Engineering or Computer Science degree.
Lead Computer Systems Validation Engineer I (Clinical & R&D)
Waltham, Massachusetts, United States
$110k-$126k/yrHybridFull Time
AlkermesNasdaq: ALKS: Public Irish biopharmaceutical developing and commercializing neuroscience medicines for people with psychiatric and neurological disorders.
7+ YOEBachelor’s degree in computer science, life sciences, engineering, or related field with 9+ years in digital quality; master’s with 7+ years considered. Requires GxP, CSV, quality systems, compliance, data integrity, and team leadership experience.
KBI Biopharma: A private biopharmaceutical CDMO serving pharmaceutical and biotechnology companies with biologics development and manufacturing.
5+ YOEBachelor's or master's degree in engineering or information technology, 5–7 years of industry experience, lab equipment and IT computer validation experience, biotech cGMP knowledge, and project management skills.
Web applications, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, email
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
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.
CelesticaNYSE: CLS: Electronics manufacturing and supply chain solutions provider.
7+ YOEBachelor's degree or equivalent education and experience, with 7–10 years of related experience. Requires complex systems design, testing, troubleshooting, technical leadership, and cross-functional coordination.
Post-Silicon Systems Validation Engineer, Annapurna Labs
Austin, Texas, United States
$144k-$194k/yrOnsiteFull Time
AmazonNASDAQ: AMZN: Multinational technology focused on e-commerce and cloud computing.
3+ YOE3+ years design or architecture experience, programming proficiency (Python/C/C++/Rust/Go/Lua), strong computer architecture knowledge, ML fundamentals, firmware/firmware-debug experience, familiarity with RTL simulation, emulation and post-silicon validation; Bachelor's in CS/engineering/math or equivalent.
Arrow ElectronicsNYSE: ARW: Global technology solutions, components, and enterprise computing provider.
5+ YOE5+ years programming; strong skills in Python, Lua, C/C++, Rust, or Go; solid computer architecture and chip/system validation knowledge; firmware testing/dev experience; Linux and Git proficiency; bachelor’s in CS/CE or related.