99 computer system validation jobs at 59 companies in Ewing, NJ
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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.
GBA: Provides engineering, architecture, and construction services for infrastructure.
10+ YOEBS in engineering,10+ years project/process engineering or validation experience,pharmaceutical/GMP experience preferred,Kneat and MS Office proficiency,excellent communication and problem-solving skills.
Kneat, Microsoft Excel, Microsoft Word, Microsoft Project, Microsoft PowerPoint, Microsoft Access
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.
CytokineticsNASDAQ: CYTK: Develops muscle-directed medicines for cardiovascular and neuromuscular diseases.
10+ YOEOver 10 years in quality assurance/CSV with GxP; experience with CSV/CSA leadership; familiar with Veeva Vault eQMS, EMA/FDA, data integrity, and regulatory inspections.
CompTech: CompTech provides IT and program management to government agencies
1+ YOE1 year help desk/deskside support experience; ability to operate and maintain computer systems and mass storage; Security+ CE and DLA CE IA role/certification (may be obtained upon hire); Secret clearance required; valid driver's license for local travel.
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
Noblis: Nonprofit science, technology, and strategy firm supporting government missions.
0+ YOEBachelor's in engineering/CS/math, 0–3 years experience in electrical/computer engineering for control systems, US citizen able to obtain Secret clearance, valid US passport or ability to obtain, 10–20% travel.
Digital Systems Validation Lead (Wayne, PA, US, 19087)
Wayne, Pennsylvania, United States
$116k-$130k/yrOnsiteFull Time
NovocureNASDAQ: NVCR: Develops non-invasive electric field therapies for solid tumor cancers.
8+ YOE8+ years in computer system validation within regulated industries; bachelor’s degree; knowledge of GAMP 5, GxP, 21 CFR 11, FDA CSA; leadership across lifecycle validation; up to 20% travel.
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 tech (minimum), Bachelor’s preferred; ~1 year telemetry/RF experience preferred; Microsoft Windows and networking knowledge; valid driver’s license; ability to lift 75 lbs; on-call participation.
Buckeye Partners: Operates midstream energy infrastructure and logistics networks for petroleum.
High school diploma; basic computer skills; MS Office; SCADA familiarity a plus; valid driver’s license; willingness to work 12-hour shifts and overtime.
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
Fred Beans Automotive Group: Automotive dealership group selling and servicing vehicles.
Maintenance technician with HVAC, plumbing or electrical experience; able to work independently, document work in computer systems, valid driver's license, 18+ years old.
Allied Universal: Global provider of physical security and facility management services.
Valid driver\u0002s license for driving posts, high school diploma or equivalent, background check and drug screen, comfortable with basic computer/tablet use; customer service and patrol experience preferred.
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.
Four Seasons Hotels and Resorts: Operates luxury hotels, resorts, and branded residential properties globally.
1+ YOE1–2 years food & beverage experience preferred, ability to operate reservation/computer systems, strong communication skills, and valid U.S. work authorization required.
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.
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.