1mo
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CSV Engineer - Automation Engineering
Lebanon or Carmel or Indianapolis
$66k-$172k/yr OnsiteFull Time
2+ YOEB.S. in Engineering required, 2+ years in FDA-regulated environments, experience with computer system validation for automation systems, knowledge of GxP/GMP and data integrity, and authorized to work in the U.S.
DCS, SCADA, BMS, MES, Historian, Building Management System, Data Historian, Automated Storage and Retrieval System, QMS, Kneat, ALM, Valgenesis, DeltaV, Rockwell, Syncade, LabVantage, OSI PI, Site Historian, GAMP, 21 CFR Part 11
1mo
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6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham or Fishers
$65k-$91k/yr OnsiteFull Time
5+ YOEBachelor's degree required; 5+ years CSV experience in GMP pharmaceutical/biotech; PLC/HMI and historian validation experience; PAT instrument integration experience preferred; ability to author CSV deliverables and perform data integrity assessments; must be local to RTP and work onsite 100%.
PLC, HMI, PAT, NIR, NTP, Historian
1w
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FOIA Data Migration & Compliance Lead - Government
Illinois or Kentucky or Kansas or Idaho or Delaware or Colorado or Nevada or Nebraska or Montana or Michigan or Maryland or Maine or Iowa or Florida or California or Utah or Ohio or New Jersey or Minnesota or Massachusetts or Indiana or Georgia or Arizona or Alabama or Wisconsin or Washington or Virginia or West Virginia or Oklahoma or Texas or Tennessee or Pennsylvania or North Carolina or New Mexico or New York or Missouri or Louisiana or Connecticut or Washington, D.C. or South Carolina or Oregon or New Hampshire
$134k-$202k/yr HybridFull Time
U.S. citizen able to obtain Public Trust. Bachelor's or equivalent, experience with government customers, data migration and integration, SQL, scripting (Python, PowerShell), data formats (JSON, XML, CSV), FedRAMP/NIST familiarity, and product/technical lead experience.
RelativityOne, Relativity, Azure, SQL, Python, PowerShell, JSON, XML, CSV, REST APIs, FOIAXpress, GovQA, Paladin
1mo
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Manager Business Solutions - Lab IT Systems Lead
Lebanon, Indiana, United States
$65k-$152k/yr OnsiteFull Time
5+ YOEBachelor's in IT/Engineering/Computer Science, 5+ years CSV experience in regulated (GMP) environment, strong data integrity and GAMP/CSV knowledge, ability to lead contract resources, and authorized to work in the U.S.
MODA, LabVantage, NuGenesis, Empower, WinKQCL, E3B, GAMP, Agile
2w
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Principal Informatics Engineer - Lilly Medicine Foundry
Indianapolis or Lebanon
$126k-$224k/yr HybridFull Time
3+ YOEBachelor's in IT/Science/Engineering,3+ years relevant IT/CSV experience,experience with LIMS/ELN/CDS/LES,CSV/IQ-OQ-PQ,API/instrument integration,data integrity and GMP familiarity,strong communication and problem-solving.
LabVantage, LabWare, Benchling, Signals Notebook, Empower, L7, MODA, Agile
3mo
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Manager - Validation Lead – Technical Support & Operations – Global Services
Indianapolis, Indiana, United States
$65k-$152k/yr OnsiteFull Time
8+ YOELead CSV/CSA activities across system lifecycle; strong knowledge of GxP, FDA and EU validation regs; 8+ years CSV experience in pharma/life sciences; Bachelor’s in CS/IT; experience with Jira, ServiceNow, Veeva; drive automation and AI-enabled validation.
Jira, ServiceNow, Veeva, Scrum, SAFe
3mo
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Advisor, Sr. Product Manager - Manufacturing Intelligence
Indianapolis, Indiana, United States
HybridFull Time
5+ YOEBachelor's degree; 5+ years tech experience; 3+ years CSV/CSQ in GxP; knowledge of manufacturing intelligence and platforms.
AVEVA PI, Seeq, Ekhosoft
2mo
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Senior MES Engineer
Fishers, Indiana, United States
OnsiteFull Time
5+ YOE5+ years of MES experience in GMP/regulatory environments; expertise in SCADA/MES platforms, ISA-88/ISA-95 familiarity, data analytics, and CSV support.
MES, SCADA, HMI, OPC, Rockwell FactoryTalk, Historian, SQL Server, Power BI, Seeq, Minitab, JMP
2d
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Informatics Engineer - Lilly Medicine Foundry
Indianapolis or Lebanon
$65k-$158k/yr OnsiteFull Time
1+ YOEBachelor's degree and 1+ year relevant experience; CSV experience; knowledge of LIMS/ELN/CDS/LES; ability to produce IQ/OQ/PQ and ensure data integrity in GMP labs.
LabVantage, LabWare, Benchling, Signals Notebook, Empower, L7, MODA, Electronic Lab Notebooks (ELN), Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS)
1mo
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Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q)
Indianapolis, Indiana, United States
$65k-$169k/yr OnsiteFull Time
5+ YOEBachelor's in a technical/scientific discipline (or equivalent experience), 5+ years quality experience in medical devices, strong QMS/validation knowledge, regulatory familiarity (FDA, ISO, MDR), CSV and supplier oversight experience.
Kneat, Agile, TrackWise, Microsoft Office
2mo
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Associate Director of Enterprise Systems
Fishers, Indiana, United States
OnsiteFull Time
12+ YOEBachelor's degree and 12+ years managing enterprise systems in regulated (GxP) environments; experience leading large ERP/MES/CMMS/VMS implementations, CSV/CSA, data integrity, integrations, team leadership, and stakeholder engagement.
SAP ByDesign, SAP S/4HANA, Microsoft Dynamics, Oracle NetSuite, Blue Mountain, Kneat, Rockwell PharmaSuite, Apprentice, Tulip, LIMS, WMS, Veeva Vault, Jira
1mo
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Senior Associate - Business Consulting
Bridgewater or New York or Indianapolis
$117k-$148k/yr OnsiteFull Time
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.
Agile, JIRA, Confluence, ALM, ServiceNow, Veeva, HPALM, GAMP 5, Waterfall
2d
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Senior DeltaV Automation Lead
Indianapolis, Indiana, United States
$110k-$128k/yr OnsiteFull Time
9+ YOEBachelor's in engineering,9+ years industrial automation experience with Emerson DeltaV,DeltaV Live graphics expertise,experience leading automation projects in GMP-regulated life sciences,validation/CSV knowledge,and TypeScript/VBA familiarity.
Emerson DeltaV, DeltaV Live, DeltaV Live Graphics Studio, TypeScript, VBA, EMR
2mo
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Digital Automation Engineer —DeltaV Central Solutions and Transformation
Indianapolis, Indiana, United States
$66k-$172k/yr OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years process automation experience with Emerson DeltaV, DeltaV Batch DCS, GMP/CSV experience, Python programming, MES/AVEVA PI familiarity, ability to translate process needs into digital requirements, US work authorization required.
Emerson DeltaV Platform, DeltaV, CLASS Module library, DeltaV Batch DCS, Python, JSON, Microsoft Excel, IBT, MES, AVEVA PI, DCS
1mo
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Senior QA Validation Specialist
Fishers, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's in science/engineering, 5+ years pharma/CDMO experience in equipment qualification and validation, hands-on FAT/SAT/IQ/OQ/PQ, cleaning validation, URS and risk assessment knowledge, ASTM E2500 and CSV familiarity, and regulatory (FDA/EMA/ICH) understanding.
ASTM E2500, Computerized System Validation (CSV), FMEA
1w
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Forward Deployment Lead, R&D Quality Strategy & Transformation
Indianapolis, Indiana, United States
$126k-$205k/yr OnsiteFull Time
5+ YOE2+ MgmtBachelor's degree required; 5+ years in pharma/biotech product or quality delivery with 2+ years leadership; hands-on technical fluency (code review, data architecture); CSV/GxP/GAMP5 knowledge; Python and Microsoft Power Platform experience; AI/ML governance and LLM delivery experience preferred.
Python, Microsoft Power Platform, Power Apps, Power BI, Power Automate
1mo
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Package Consultant 3
Austin or Hartford or Indianapolis or Raleigh or Richardson or Tempe or United States
OnsiteFull Time
Hands-on Boomi AtomSphere integration design/development, REST/SOAP/XML/JSON and flat file experience, ability to design solution architecture and lead large data migrations; bachelor\u0002s degree or equivalent experience; must be authorized to work in the US without employer sponsorship.
Boomi AtomSphere, Boomi, REST, SOAP, XML, JSON, CSV, iPaaS, Cloud Integration and API Management, TIBCO, Vitria, webMethods, IBM WBI, SAP NetWeaver
1mo
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OneStream Integration Lead
Chicago or Milwaukee or Dallas or Columbus or Kirkland or Cincinnati or New York City or Cleveland or Oklahoma City or Austin or Albany or St. Petersburg or Hartford or Pittsburgh or St. Louis or Miami or Sacramento or Raleigh or Minneapolis or Mountain View or Scottsdale or San Francisco or Morristown or Denver or Boston or Philadelphia or Des Moines or Overland Park or Los Angeles or Charlotte or Walnut Creek or Carmel or Seattle or Houston or Arlington or Atlanta or Redmond or Bentonville or Beaverton or Nashville or Detroit or San Diego
$63k-$219k/yr FieldFull Time
3+ YOEMinimums include 2+ years OneStream end-to-end integration experience, 3+ years data transformation and reconciliation experience, 2+ years documenting architecture, Bachelor's degree or equivalent, and experience with REST APIs, SIC, and ERP systems.
OneStream XF, OneStream Workflow Scheduler, OneStream Marketplace, SAP, Oracle, Workday, Dynamics, Snowflake, REST APIs, SIC, CSV, XML, JSON, C#, Cognos TM1, Hyperion, Anaplan, Adaptive, Host Analytics
1mo
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Enterprise Solutions Architect (Hybrid work schedule)
Addison or Plattsburgh or Fort Wayne
$131k-$176k/yr HybridFull Time
8+ YOEMinimum 8 years enterprise application design experience (4+ years in architecture/lead role); deep SAP S/4HANA and multiple SAP module expertise; cloud (AWS/Azure/GCP) and integration (IDOCS, ODATA, REST/SOAP, RFC, CPI) experience; bachelor’s in CS/IS or equivalent; strong communication.
SAP S/4HANA, SAP BTP, Cloud Platform Integration (CPI), ABAP, AWS, Azure, GCP, IDOCS, ODATA, CXML, CSV, REST, SOAP, RFC, Datasphere/BCP, TOGAF, SAP EA Framework, SD, MM, PP, FI/CO, GTS, WM/EWM, WMS
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