GxP jobs in Indianapolis, IN

Technical Project Manager - SaMD / GxP Validation

Remote

•

Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Cloud Infrastructure Engineer

Indianapolis, Indiana

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Today

Position Overview We are seeking an experienced Cloud Infrastructure Engineer to design, implement, and maintain secure, scalable, and reliable cloud-based solutions across AWS and/or Azure. In this role, you will optimize cloud infrastructure, drive automation through Infrastructure-as-Code (IaC) and CI/CD, and ensure rigorous adherence to security, performance, and regulatory standards for enterprise and research applications. Key Responsibilities Cloud Architecture & Infrastructure: Design a

Full-time

USD 187,200.00 - 214,200.00 per year

IT Subject Matter Expert (ITSME) EHR-to-EDC Integration

Indianapolis, Indiana

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Today

Role Summary The ITSME is the technical authority for integrating eSource systems (eCOA/ePRO, eConsent, EHR-to-EDC connectors, wearables and sensor platforms, and site-facing source capture tools) into the clinical development data landscape. The role designs and builds the interfaces that move source data reliably, compliantly, and with full traceability from point of capture to downstream systems such as EDC, CTMS, and the clinical data repository. Key Responsibilities Design and develop integ

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Full-time, Part-time, Contract, Third Party

SAP Architect - Logistics

Indianapolis, Indiana

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Today

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driv

Full-time

Helpdesk Tech II

Fishers, Indiana

•

Today

Description Helpdesk Technician II Summary We are seeking a Helpdesk Technician II who is customer-focused, collaborative, and technically strong. This role provides hands-on support for end users across the organization, resolves hardware, software, and access issues, and follows established procedures in a GxP-regulated pharmaceutical environment. The Helpdesk Technician II works closely with the Helpdesk Technician and the infrastructure team to deliver reliable, timely support. We are hi

Full-time

Business Quality Analyst- LabVantage

Indianapolis, Indiana

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Today

Job#: 3056660 Job Description: Role: Business Quality Analyst - LabVantage Duration: 10+ month Contract Location: Remote Apex Systems, a Global Life Sciences Consulting Organization, is seeking an experienced Business Quality Analyst to support a global LabVantage LIMS upgrade within a highly regulated pharmaceutical environment. This role will focus on LabVantage System Quality and the quality and validation activities required to successfully implement the upgraded platform. This is not a Me

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Full-time

$50 - $55 per hour

Principal Data Engineer

Indianapolis, Indiana

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Today

Full-time

Principal Site Reliability Engineer

Indianapolis, Indiana

•

Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 66,000.00 - 158,400.00 per year

SAP Validation

Remote

•

24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Business Systems Analyst III

Remote

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7d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration Sumtotal LMS experience is required. 12 month remote contract. $40 an hour w2. No C2C or 1099 at this time. EST or CST candidates preferredPosition SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the li

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Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration12 month remote project - Candidates should sit in CST or EST time zone. $40 an hour w2. No Corp to Corp or 1099 support at this time. Position SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the liaison

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Contract

Depends on Experience

Business Systems Analyst III

Remote

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7d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Easy Apply

Contract

Depends on Experience

Associate Director - Technology at Lilly Procurement

Indianapolis, Indiana

•

Today

Full-time

USD 132,000.00 - 193,600.00 per year

ERP Systems Analyst

Fishers, Indiana

•

Today

Description Are you an IT professional looking for an exciting opportunity with an organization where you can have an impact on global health and wellness? We are looking for a Senior ERP Systems Analyst who will help with our growing IT department. Do you naturally create new ways to deliver exceptional results? We want to meet you! Role Summary The ERP Systems Analyst - SAP Business ByDesign is a hands-on system support resource responsible for the day-to-day administration, configuration

Full-time

Sr. IT/OT Infrastructure Engineer - Manufacturing Digitalization at Cincinnati, OH (Remote)

Remote

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9d ago

Position: Senior IT/OT Infrastructure Engineer - Manufacturing Digitalization Location: Cincinnati, OH (Remote) Duration: 3+ Months Job Description: We are seeking an experienced Senior IT/OT Infrastructure Engineer Manufacturing Digitalization to support manufacturing equipment digitalization, network connectivity, Data Integrity (DI) upgrades, MERA network onboarding, and VxRail infrastructure within a regulated manufacturing environment. The role will provide hands-on IT/OT infras

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Contract, Third Party

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

Loftware Spectrum Technical Lead

Remote

•

Today

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Third Party, Contract

Depends on Experience

GxP jobs in Indianapolis, IN, USA