58 computer system validation jobs at 42 companies in New Jersey
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Computer System Validation (CSV) Engineer
Piscataway, New Jersey, United States
OnsiteFull Time
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
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.
Computer System Validation - Senior Consultant - Life Sciences
New York or Boston or Chicago or Hoboken or McLean or Pittsburgh or Philadelphia or Washington
$94k-$155k/yrHybridFull Time
EY: Global firm providing audit, tax, and professional consulting services.
3+ YOEBachelor's degree in a technical field and 3+ years life sciences validation experience; strong CSV, SDLC/Agile, GxP/regulatory and risk-based validation knowledge.
Validation Analyst/Senior Validation Analyst, Clinical Research
North Carolina or New Jersey or New York or Georgia or Pennsylvania or Illinois or Texas or Maryland or Massachusetts or Florida or Virginia
$76k-$126k/yrRemoteFull Time
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
5+ YOE5+ years validating regulated computer systems (CSV) in GxP environments; SDLC experience; knowledge of FDA 21 CFR Part 11, GAMP5, risk-based validation; strong writing and stakeholder skills.
Jira, Azure DevOps, HP ALM, CTMS, eTMF, EDC, LIMS, ERP, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Project
ZT SystemsNASDAQ: SANM: Manufactures custom server and storage hardware for data centers.
0+ YOEBachelor's in Electrical/Computer/Systems Engineering or related field; 0-2 years in electrical/system test/validation; scripting for testing; ability to report findings clearly.
WuXi BiologicsHong Kong Stock Exchange: 2269: Provides discovery, development, and manufacturing services for biologic drugs.
BS in engineering or science (or equivalent experience); experience in FDA-regulated industry or equipment qualification/validation; understanding of cGMP/GXP/GAMP, 21CFR part 11, computer systems validation and SDLC; technical writing and strong communication skills.
Kaye Validator, clamp meter, RTD probe, Process Control Systems Validation (CSV), Software Development Life Cycle (SDLC), 21CFR part 11
InfosysNYSE: INFY: Provides IT consulting, software development, and business outsourcing services.
5+ YOE5+ years life sciences experience; strong knowledge of CSV, validation deliverables, 21 CFR Part 11, GxP, GAMP 5; experience with Agile, JIRA, Confluence, ALM; ability to guide teams and support audits.
MindrayShenzhen Stock Exchange: 300760: Develops and manufactures medical diagnostic and monitoring equipment.
1+ YOEAssociate degree in electronics/instrumentation/computer technology (minimum), 1+ year telemetry/RF experience preferred, Microsoft Windows and networking knowledge, valid driver’s license, ability to lift 75 lbs, travel and on-call availability.
Associate Director, Metrologist and Compliance Lead, Medical Devices and Combination Products
Rahway, New Jersey, United States
$142k-$224k/yrOnsiteFull Time
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
5+ YOEDegree in engineering/physics/metrology,5+ years industry experience supporting ISO 13485 labs,expertise in metrology,calibration,IQ/OQ,computer system validation,design controls,risk management,and quality systems.
Electronic Document Management System (EDMS), Laboratory Information Management System (LIMS), Calibration Management Software, Keyence, Instron, Zwick, Texture Analyzer
Madison Honda: Automotive dealership for new and used Honda vehicles.
Experience in body shop estimating, proficiency with CCC Estimating System, valid driver’s license, Reynolds & Reynolds experience preferred, strong communication and basic computer skills.
Burlington StoresNYSE: BURL: Off-price retailer of apparel, footwear, and home goods.
Inspect inbound freight and product, validate documentation and system records, follow SOPs, and escalate issues; high school diploma and basic computer/math skills required.
Pennsylvania or East Windsor or Reston or Mansfield or Montgomery
$90k-$125k/yrFieldFull Time
Thermo Systems: Integrates industrial control systems and automation engineering solutions.
7+ YOEBachelor's in engineering or computer science, typically 7+ years experience, 3+ years as control systems project engineer, leadership and project management skills, valid driver's license.
7+ YOE7+ MgmtBS in engineering or science required; 7+ years pharmaceutical validation experience and 7+ years managing personnel/projects; expert knowledge of cGMP/GXP/GAMP/SDLC and computer systems validation; strong communication and leadership skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, CMMS, database systems
360 Networks: Provides managed IT services and 24/7 technical support solutions.
3+ YOE3+ years installing low-voltage cabling, IP camera systems and TVs; computer-literate; mechanically inclined; strong troubleshooting; valid driver's license and clean driving record.
InsmedNasdaq: INSM: Global biopharmaceutical developing therapies for serious, rare diseases.
3+ YOEBachelor's degree,3+ years LMS administration experience in pharmaceutical/biotech,understanding of computer system validation,knowledge of global regulatory/compliance requirements,highly organized with attention to detail.
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
10+ YOEBachelor's in engineering or computer science, 10+ years automation/PLC/SCADA experience in manufacturing, system development and validation expertise, knowledge of 21 CFR Part 11, vendor and project leadership skills.
PLCs, SCADA, DCS, Data Historian, ERP, MES, HMI, Cognex, Keyence, Omron, ladder logic, AI
2+ YOE2+ years retail/hospitality experience with cash handling, must be 21+, valid driver’s license or state ID, computer literate with POS and inventory systems, strong customer service and communication skills.
Alpine IQ, Leaflogix, MJ Freeway, Veriscan, Microsoft Office, Microsoft Outlook, Metrc