467 computer system validation manager jobs at 340 companies in United States
3w
Save
Mark Applied
Hide
3w
Computer System Validation
Wilmington, Delaware, United States
$125k-$150k/yrOnsiteFull Time
Tata Consultancy ServicesBSE: 532540: Global leader in IT services, consulting, and business solutions.
8+ YOE8+ years CSV experience in GxP environments, knowledge of Part 11/Annex 11, authoring validation deliverables, risk-based validation, and stakeholder management.
AstellasTokyo Stock Exchange: 4503: Public Japanese pharmaceutical researching, manufacturing, and selling prescription medicines for patients worldwide.
5+ YOEBachelor's degree, 5–8 years computer system validation in pharma/biotech, deep knowledge of GxP/GAMP 5/21 CFR Part 11/Annex 11, experience validating LIMS/MES/QMS/ERP/OSI PI/Empower/SAP/LabWare, strong technical writing and project management.
LIMS, MES, QMS, ERP, OSI PI, Empower, SAP, LabWare, GAMP 5, 21 CFR Part 11, EU Annex 11
4D Molecular TherapeuticsNasdaq: FDMT: Public clinical-stage biotechnology developing targeted gene therapies for serious unmet medical conditions.
5+ YOEBachelor’s degree and 5–7 years in biopharmaceuticals, including 4+ years in QA CSV. Requires clinical systems validation, GxP compliance, regulatory knowledge, risk-based validation, and audit support.
Corcept TherapeuticsNasdaq Capital Market: CORT: Public biopharmaceutical developing and commercializing cortisol-modulating medicines for severe endocrine, cancer, metabolic, and neurologic disorders.
8+ YOE8+ years experience in QA/validation for computerized systems in pharma, knowledge of 21 CFR Part 11/Annex 11/GAMP5, data integrity, strong communication, and ability to manage vendors and consultants.
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.
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
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.
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)
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
3+ YOEBachelor’s degree in computer science, engineering, or related field; 3+ years of computer systems validation and cGMP facility experience; knowledge of 21 CFR Part 11 and ISPE GAMP guidelines.
Computer Systems Validation (CSV), Quality Management System (QMS), Change Control, CAPAs, Computerized systems, 21 CFR Part 11, ISPE GAMP
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.
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
Director, QA Validation & Computer Systems Assurance
Saratoga Springs or Rensselaer
$172k-$287k/yrOnsiteFull Time
Regeneron PharmaceuticalsNASDAQ: REGN: Biotechnology discovering and developing life-transforming medicines.
12+ YOE5+ MgmtBS/BA in engineering/computer science/life sciences,12+ years pharma manufacturing experience with 7+ years in validation/CSA,5+ years people management,knowledge of GAMP 5/SDLC/FDA CSA/21 CFR Part 11/Annex 11,experience with MES/DCS/LIMS/ERP for GMP.
GAMP 5, SDLC, MES, Syncade, PAS-X, DCS, SCADA, LIMS, EBR, ERP, data historian
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.
Sr Computer Systems Validation Analyst (Clayton, NC, US)
Clayton, North Carolina, United States
OnsiteFull Time
Novo NordiskNasdaq Copenhagen / NYSE: NOVO B / NVO: Global healthcare dedicated to defeating serious chronic diseases.
7+ YOEBachelor's in IT/Engineering/Science required; 7+ years IT compliance and 5+ years validation/testing experience; CSQE/COBIT/Lean Six Sigma preferred; experience with HP ALM, GxP, change management, and MS Office; strong communication and problem-solving skills.
Director, QA Validation & Computer Systems Assurance
Saratoga Springs or Rensselaer
$172k-$287k/yrOnsiteFull Time
Regeneron PharmaceuticalsNASDAQ: REGN: Biotechnology discovering and developing life-transforming medicines.
12+ YOE5+ MgmtBS/BA in engineering, CS, or life sciences; 12+ years pharma manufacturing experience with 7+ in validation/CSA, 5+ years managing people; CSA/CSV leadership experience; GxP software/SDLC knowledge; MES/DCS/LIMS experience.
TekSynap: Technology moving at the speed of thought.
1+ YOE1+ year relevant experience, active Secret clearance, valid driver's license and insurance, one active IAT II/III certification or equivalent, ability to operate and test integrated computer systems and manage tickets.
Navy Certificate Validation Infrastructure System Administrator
North Charleston, South Carolina, United States
$72k-$150k/yrOnsiteFull Time
CACINYSE: CACI: Provider of specialized IT and mission-critical government services.
8+ YOE3+ MgmtActive DoD Secret clearance; ability to obtain Top Secret/SCI; bachelor's degree or equivalent; 8–10 years of systems, network, or cybersecurity experience; 3 years of technical leadership; DoD PKI experience; IAT Level II and computing environment certification.
Online Certificate Status Protocol (OCSP), Certificate Revocation List (CRL), Red Hat Enterprise Linux (RHEL), Windows Server, Consolidated Afloat Networks and Enterprise Services (CANES), Active Directory, LDAP, Common Access Card (CAC), ACAS, Nessus, DISA Security Technical Implementation Guides (STIGs), SIPR
Chicago or San Francisco or Los Angeles or New York City or Denver or Boston
$103k-$210k/yrOnsiteFull Time
Crowe: Global public accounting, consulting, and technology firm.
4+ YOEBachelor's or advanced degree in data, finance, computer science, information systems, statistics, or mathematics; 4+ years in financial crime and model validation; analytical, testing, stakeholder, and project management skills.
Cowboy Space Corporation: Space infrastructure building orbital AI data centers and a solar-powered power grid for AI workloads.
5+ YOE5+ years validating and debugging compute hardware with expertise in motherboard architecture, high-speed signaling, power delivery, system management, and lab instrumentation; proficiency in Python or C/C++ and cross-functional collaboration.
Navy Certificate Validation Infrastructure System Administrator
North Charleston, South Carolina, United States
$72k-$150k/yrOnsiteFull Time
CACINYSE: CACI: Provider of specialized IT and mission-critical government services.
8+ YOE3+ MgmtActive DoD Secret clearance and ability to obtain Top Secret/SCI; bachelor's degree or equivalent; 8–10 years of IT experience, 3 years of technical leadership, 2 years of DoD/Navy PKI experience, and required baseline and computing environment certifications.
Public Key Infrastructure (PKI), Online Certificate Status Protocol (OCSP), Certificate Revocation List (CRL), Red Hat Enterprise Linux (RHEL), Windows Server, Consolidated Afloat Networks and Enterprise Services (CANES), Active Directory, LDAP, Common Access Card (CAC), Nessus, ACAS, DISA Security Technical Implementation Guides (STIGs), SIPR, VMware