142 fda jobs at 65 companies in Indianapolis, IN
2d
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Plasma Center - EMT-B
Greenwood, Indiana, United States
$20-$29/hr OnsiteFull Time
2+ YOEHigh school diploma or equivalent, current state EMT or nursing license/certification, CPR and AED certification, basic IV therapy eligibility, FDA training, and two years in a clinical or hospital setting.
Serological Protein Electrophoresis (SPE), FDA
1mo
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Senior QA Engineer
Greenwood, Indiana, United States
OnsiteFull Time
5+ YOE2+ MgmtBachelor's in engineering or related field,5+ years QA in manufacturing/distribution,2+ years managing quality staff,experience with ISO 13485/MDSAP/FDA,QMS,CAPA,root-cause methods.
ISO 13485, MDSAP, FDA, A3, 8D, DMAIC
1d
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Pharmacist
Indianapolis, Indiana, United States
OnsiteTemporary
Current pharmacist license, pharmacy bachelor's degree required and PharmD preferred, knowledge of drug therapy, medication safety, CMS, DEA, FDA, EMR, and pharmacy information systems; one year of long-term care experience desired.
Electronic Medical Records (EMR), pharmacy information systems, CMS, DEA, FDA
1w
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Assembler II
Noblesville, Indiana, United States
$22/hr OnsiteFull Time
1+ YOEMinimum ~1 year manufacturing experience preferred; perform brazing, leak testing/charging, wiring, foaming, final test, and sheet metal assembly; follow FDA GMP and DHR procedures; train new employees; comply with safety and attendance policies.
basic hand tools, Device History Records (DHR), FDA GMP
2mo
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Quality Supervisor, Life Science Division 2nd shift
Whitestown, Indiana, United States
OnsiteFull Time
3+ YOELead quality team in raw material sampling; ensure GMP/FDA compliance; manage quality systems and audits; drive continuous improvement.
LIMS, Raman, Calipers, Go/No Go gauges, Microsoft Office
2w
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Engineer, Process - Drug Substance
Bloomington, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in related field and minimum 2 years project engineering experience; experience with bioprocess equipment, troubleshooting, SOPs, validation, and FDA GMP expectations.
3mo
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Medical Screener (Indianapolis, IN, US, 46241)
Indianapolis, Indiana, United States
OnsiteFull Time
1+ YOEHigh school diploma; 1+ year customer service; Louisiana Clinical Laboratory Personnel license; flexible hours; familiar with FDA, cGMP, OSHA a plus.
NDDR, CDCS, Vital signs equipment
3w
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Production Manager
Fishers, Indiana, United States
OnsiteFull Time
Plan and control medical-grade injection molding and automated assembly production, ensure ISO/FDA/GMP compliance, lead continuous improvement, and supervise production staff.
ERP, MRP, Microsoft Office
2w
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QA TECHNICIAN 1
Mooresville, Indiana, United States
$20/hr OnsiteFull Time
High school diploma, familiarity with cGMP/FDA/OTC standards, batch record review and release experience, strong attention to detail, communication, and eQMS/ERP proficiency.
Microsoft Office Suite, Red Prairie, SAP, AS400, Dynamic 365, Oracle, Intelex, MasterControl, Harford, LIMS, Labware, Specright
4w
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Environmental Health and Safety Specialist
Brownsburg, Indiana, United States
OnsiteFull Time
1+ YOESupport EHS for radiopharmaceutical manufacturing ensuring compliance with NRC, FDA, DOT, OSHA, EPA; perform radiation safety, inspections, incident investigations, training, and records management.
3w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's in life science or engineering, 4+ years pharmaceutical operations experience, knowledge of US/EU GMP and FDA, project management, process investigations, and equipment design.
Microsoft Visio, AutoCAD, Minitab, JMP, Microsoft Suite, Kepner-Tregoe, FMEA, PLC
2w
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Production Operator, 1st Shift
Indianapolis, Indiana, United States
OnsiteFull Time
Assemble, test, and package medical and electronic devices per procedures; attention to detail, good documentation, ability to stand/lift, and follow ISO/FDA quality requirements.
ERP
13h
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's degree in chemistry, biochemistry, chemical engineering, biochemical engineering, life science, or engineering; 4+ years in pharmaceutical operations and US and European GMP and FDA requirements.
Microsoft Suite, Microsoft Visio, AutoCAD, Kepner-Tregoe, Root Cause Analysis, FMEA, Minitab, JMP, P&IDs, PLC
5d
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Warehouse Operations Manager
Brownsburg, Indiana, United States
HybridFull Time
5+ YOE3+ MgmtRequires 5+ years in pharmaceutical, biotech, or regulated warehouse operations, including 3+ years in leadership; knowledge of GDP, GxP, FDA/EMA, WMS, Excel, and process improvement.
Microsoft Excel, Microsoft Outlook, Microsoft Teams, Microsoft Office, Blue Yonder, Warehouse Management Systems (WMS)
1mo
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Quality Specialist - Dry Sweeteners
Indianapolis, Indiana, United States
OnsiteFull Time
Heartland Food Products Group: Produces and markets low-calorie sweeteners and cold brew coffee.
1+ YOEBS degree, 1+ years food manufacturing QA experience, HACCP preferred, SQF and FDA knowledge, strong QA/cGMP skills, documentation and corrective action experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's degree in a life science or engineering discipline and 4+ years in pharmaceutical operations and US and European GMP requirements and FDA guidelines. Strong technical engineering and project skills required.
Microsoft Suite, Microsoft Visio, AutoCAD, JMP, Minitab, PLC
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
2w
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Project Manager, CQV
Indianapolis, Indiana, United States
OnsiteFull Time
7+ YOE7+ years validation/project management experience in life sciences or FDA-regulated environments, BS in engineering, strong cGMP/validation, risk assessment, technical writing, and leadership skills.
GAMP, 21 CFR Part 11, FMEA, HAZOP, Fault Tree Analysis
3w
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Medical Delivery Driver - CDL
Columbus, Indiana, United States
FieldFull Time
Performs deliveries of oxygen and equipment, maintains vehicle and equipment, follows DOT/FDA/OSHA standards; high school diploma, valid driver’s license, CDL and hazmat required or to be obtained.
3w
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Engineer 2, Sterilization
Ellettsville, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in engineering, minimum 2 years experience, knowledge of GMP/FDA 21 CFR/ISO standards for sterilization, AutoCAD/REVIT, Microsoft Office, PLC experience, and ability to travel ~20%.
AutoCAD, REVIT/BIM, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, PLC
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