Computerized System Validation jobs in Greenfield, IN

Hybrid in Indianapolis, Indiana

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Today

Automation Area Lead DeltaV Indiana, IN (Hybrid) Minimum 1 week a month in Indiana during the basic/detailed design phase of the project. Full-time on-site during the Commissioning phase of the project Project-based role, Duration 3 years The Automation Area Lead will be responsible for the control system solution for an area within a project, ensuring the solution is aligned with the overall program automation philosophy, standards, and user requirements. The area lead will work in conjunction

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Contract, Third Party

Depends on Experience

Computer System Validation Engineer 1

Remote

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Today

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

CSV Engineer

Indianapolis, Indiana

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Today

Responsibilities: Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans. Support execution of validation activities in alignment with the approved Validation Plan and CSV documentation standards. ssist Project CSV Leads in generating/editing CSV documents and electronic testing templates. Recom

Full-time

Engineer - FUME & CSQ PRD Quality Assurance

Indianapolis, 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 65,250.00 per year

Sr. Principal Infrastructure Architect - Manufacturing & Quality Systems

Indianapolis, Indiana

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Today

Full-time

USD 126,000.00 - 224,400.00 per year

Corporate Automation Project Engineer - Drug Product

Indianapolis, Indiana

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Today

Full-time

USD 66,000.00 per year

IT Systems Specialist- Clinical

Indianapolis, Indiana

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Today

Job#: 3010828 Job Description: Role: IT Systems Specialist Location: Indianapolis, IN Type: Long Term Contract Apex Systems, a global Technology Services leader, is looking for an IT Systems Specialist for a large life sciences client. This is a long term contract role and is on site in Indianapolis, IN. See below for more details! Core Responsibilities Computer Systems Quality Documentation: Create and maintain documentation aligned with regulatory and Info Sec standards Computer Systems Val

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Full-time

CSV Support Engineer

Greenfield, Indiana

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Today

Responsibilities: Empower Administration & Support. Manage user accounts, access rights, roles, and privileges in Empower. Perform system configuration, project management, and template/report customization. Provide day-to-day L2/L3 support for Empower users across QC/analytical labs. Instrument Integration & Troubleshooting. Integrate lab instruments (HPLC, UPLC, Dissolution, UV, etc.) with Empower. Troubleshoot connectivity, data acquisition, and communication issues between instruments and C

Full-time

Google Document AI / OCR Specialist

Remote or Seattle, Washington

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Today

Description Robert Half is seeking a Google Document AI Specialist (OCR Consultant) to support a healthcare organization based in Washington State (Remote). This role involves extracting structured data from scanned and typed documents stored in a Google Cloud project using Google Document AI, as the client needs a consultant to configure templates, run batches, and deliver accurate CSV outputs. The position is Remote, and is a short-term ~20-hour contract with potential for follow-up work. Appl

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Contract

USD 60.00 - 90.00 per hour

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

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Today

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

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Contract, Third Party

SAP GTS Led

Remote

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15d ago

Title: SAP GTS Led Location: Remote JD: 1. Minimum of 15 years of experience designing, developing, testing, and deploying solutions in SAP with a focus on international business and you have a minimum of 3 years of direct experience with the SAP GTS module and/or SAP GTS E4H 2. Must have upgrade experience with GTS E4H 3. Experience solving complex international and multi-plant distribution scenarios, including Order Routing between plants, the import of good into the United States, and the e

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Contract, Third Party

Depends on Experience

COBOL Programmer

Remote or Seattle, Washington

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Today

Description Robert Half is seeking a highly experienced COBOL Data Migration Specialist to support a major migration effort from a legacy COBOL-based system to a new cloud-based platform (Kubernetes-based). This role requires deep hands-on expertise with COBOL data structures, legacy extraction, and large-scale data migration. The contractor will act as the primary SME for all COBOL data and will work with minimal internal guidance. Duration: 1-month contract with potential for extension Locatio

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Contract

USD 50.00 - 65.00 per hour

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Azure Data Engineer

Remote

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2d ago

Azure Data Engineer Location: Remote Employment Type: Contract/Full Time Any Visa will workJob Summary We are looking for an experienced Azure Data Engineer with 5 6 years of hands-on experience in designing, building, and maintaining scalable data solutions on Microsoft Azure. The ideal candidate will work closely with data architects, analysts, and business stakeholders to deliver reliable, high-performance data pipelines and analytics platforms. Roles & ResponsibilitiesDesign, develop, and

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Contract

$60 - $65

KeyCloak Engineer

Remote

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Today

Leidos Digital Modernization Sector is looking for a Keycloak Engineer to work on the Army Global Unified Network (AGUN) - Increment 1 (INC1) program. The Global Enterprise Network Modernization - OCONUS (GENM-O) is a critical mission provider responsible for keeping the Army connected through global network modernization projects. The Army Global Unified Network (AGUN) - Increment 1 (INC1) will unify the next generation of Army transport to comply with the Joint Regional Security Stack (JRSS) d

Full-time

USD 92,300.00 - 166,850.00 per year

Senior AI Engineer

Remote or Woonsocket, Rhode Island

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Today

At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues - caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all w

Full-time

USD 92,700.00 - 222,480.00 per year

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Validation Engineer III

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

Computer Systems Quality Assurance (CSQA) with Validation (CSV)

Indianapolis, Indiana

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17d ago

Job Title: Computer Systems Quality Assurance (CSQA) with Validation (CSV) Location: Indianapolis, IN (Onsite) Duration: 12+ Months Job Description: Please not that 1 F2F round is mandatory. Mandatory skills: IT CSV Validation of IT systems IT QA / QA eCompliance Manager Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM Pharma industry experience is mandatory Medical device experience is good to have This Computer Systems Quality Assurance role will be responsible for supporting

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Full-time, Contract, Third Party

$DOE

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

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Computerized System Validation jobs in Greenfield, IN 46140, USA