21 CFR Part 11 jobs in Lebanon, IN

Lebanon, Indiana

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3d ago

Position- Senior Validation Engineer, Local Type- ONSITE Location- Lebanon, IN Visa- GC Key Responsibilities Engineering & System DesignDesign and develop BMS and automation solutions for GMP/GxP-regulated pharmaceutical, biotech, and life sciences facilities.Support critical environments including cleanrooms, laboratories, manufacturing suites, central utilities, and process support systems.Develop control strategies and automation architectures for HVAC, chilled water, steam, compressed air,

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Third Party, Contract

Depends on Experience

Sr. Computerized System Validation (CSV) Manager

Remote

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3d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager with CRO industry experience. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, a

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Full-time

Depends on Experience

Senior Validation Specialist- BMS

Lebanon, Indiana

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26d ago

Lead the BMS validation lifecycle across all 8 LMF buildings, from URS authoring through Validation Summary Report and closeout.Author and obtain approval for User Requirement Specifications (URS) for the Metasys BMS platform.Engage JCI on Software Requirement Specifications (SRS) review and acceptance.Develop and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Risk based approach adhering to Lilly Q

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Contract

Depends on Experience

CSV Engineer- Automation

Lebanon, Indiana

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26d ago

Lead validation lifecycle activities for automation and control systems at LMF, including DeltaV, PI Historian, Rockwell PLC/HMI, and Metasys platforms.Develop and execute validation plans (VP), user requirement specifications (URS), functional specifications (FS), design specifications (DS), and configuration specifications (CS) for automation systems.Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Generate and mai

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Contract

Depends on Experience

Sr. Equipment Validation Engineer

Lebanon, Indiana

•

Today

Job#: 3031486 Job Description: Role: Sr. Equipment Validation Engineer Location: Leabanon, IN (On-Site) Type: Long Term Contract Apex Systems, a global leader in Technology Services, is searching for a Sr. Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details! Duties and Responsibilities: Supports t

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Full-time

Testing Validation Veeva : Indianapolis, IN-Onsite

Indianapolis, Indiana

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4d ago

Testing Validation Location: ~Indianapolis, IN~ Duration: 6 months Role Descriptions: Key Responsibilities Testing Validation Design| develop| and execute test plans| test scripts| and test cases for Veeva Safety modules in accordance with GxP validation standards. Lead and perform all phases of testing including Unit Testing| System Testing| Integration Testing| User Acceptance Testing (UAT)| and Regression Testing. Develop and maintain validation documentation including Validation

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Contract, Third Party

$50 - $55

Informatics Engineer - Lilly Medicine Foundry

Lebanon, Indiana

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 64,500.00 - 158,400.00 per year

Software Engineer, AI & Clinical Applications

Indianapolis, Indiana

•

Today

Full-time

USD 64,500.00 - 158,400.00 per year

LabVantage LIMS Engineer

Remote

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12d ago

Provide L2/L3 incident resolution for LIMS applications (LabVantage or LabWare). Diagnose and resolve configuration issues, workflow errors, sample lifecycle problems, and data inconsistencies. Conduct detailed root-cause analysis and implement permanent fixes. Maintain LIMS master data, workflows, templates, and stability modules. Support version upgrades, patches, and environment maintenance. Assist laboratory users with operational questions, access issues, and data troubleshooting. Support i

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Third Party, Contract

Depends on Experience

Manager - Validation Lead - Technical Support & Operations - Global Services

Indianapolis, Indiana

•

Today

Full-time

USD 64,500.00 - 151,800.00 per year

Senior UiPath RPA Developer - Provider - Epic

Remote

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4d ago

Genzeon, an AI and automation company with deep engineering and data expertise, dedicated to serving the healthcare and retail industries. Our platform solutions including HIP One, CompliancePro Solutions, and Patient Engagement Solutions empower organizations to scale innovation and transform outcomes. Genzeon is a global community of innovators and problem-solvers, with a culture built on inclusion, flexibility, and purpose-driven work. With four global delivery centers, we support providers

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Third Party, Contract

Depends on Experience

Principal Data/AI Engineer

Remote

•

Today

Position Overview The Principal Data/AI Engineer helps drive the technical strategy and architecture of enterprise-scale data and AI platforms that power mission-critical data products, analytics, and AI-driven solutions. In this role, you will operate as a technical expert in planning, designing, developing, and debugging new and existing data pipelines. You will advocate for data and AI engineering best practices, including idempotent modular pipeline design, version control, automated testin

Full-time

USD 146,000.00 - 241,000.00 per year

Staff Enterprise Applications Developer - IBM Maximo

Remote or San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 116,600.00 - 194,400.00 per year

Specialist IS Engineer

Remote or Thousand Oaks, California

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Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati

Full-time

USD 138,674.00 - 144,146.00 per year

DIRECTOR OF TECHNOLOGY SOLUTIONS, DCRI

Remote or Durham, North Carolina

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Today

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,

Full-time

Associate Director, Data/AI Solution Architect, PDM & Tech Ops - Foster City

Remote or Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 195,670.00 - 253,220.00 per year

Associate Director, External Data Management

Remote or Warren, Michigan

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Today

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron's procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strateg

Full-time

USD 157,200.00 - 256,600.00 per year

Engineer - Automation Engineering - Control System Data Analyst- Lilly Medicine Foundry

Lebanon, Indiana

•

Today

Full-time

USD 66,000.00 per year

MES Engineer

Indianapolis, Indiana

•

Today

Job Summary : We are seeking an experienced MES Engineer with strong Pharma domain experience to support and enhance Rockwell Automation Pharma Suite (Factory Talk Production Centre) in a regulated manufacturing environment. The ideal candidate must have hands-on experience working in GxP-compliant pharmaceutical manufacturing, supporting shop-floor systems, and ensuring compliance with regulatory standards. Roles & Responsibilities : Design, configure, implement, and support Rockwell PharmaSuit

Full-time

Advisor, Data Scientist - CMC Data Products

Indianapolis, Indiana

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Today

Full-time

USD 126,000.00 - 244,200.00 per year

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21 CFR Part 11 jobs in Lebanon, IN 46052, USA