69 computer system validation jobs at 42 companies in Bethlehem, PA
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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
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.
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.
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.
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.
webuyanycar.com USA: Direct car buying service with instant valuations and payments.
High school diploma or GED; valid state driver\u00139s license; customer-facing or sales experience preferred; comfortable using standard computer applications and sales systems.
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
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.
Kia on the Boulevard: A dealership parts department providing parts support to technicians and customers in a modern service environment.
Provide parts support to technicians and customers, maintain inventory, process transactions, and communicate updates. Requires valid driver's license, attention to detail, and basic computer/inventory system skills.
2+ YOE2+ years retail/hospitality with cash handling, must be 21, valid driver's license or state ID, computer literate with POS and seed-to-sale systems, strong communication and organizational skills.
Alpine IQ, LeafLogix, MJ Freeway, Veriscan, Microsoft Office, Outlook, Metrc