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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
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
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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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