CSV Engineer jobs in Indiana

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

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

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

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

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

Senior Principal Engineer - Automation Engineering - CSV

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 per year

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

Indianapolis, Indiana

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12d 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

Easy Apply

Full-time, Contract, Third Party

$DOE

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Full-time

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CSV Engineer jobs in Indiana, USA