• CSV Associate - QC Lab Support

    Lilly (Indianapolis, IN)
    …and purchasing equipment; authoring Equipment Qualification (EQ) and Computer System Validation ( CSV ) packages, managing the EQ and CSV processes, and providing ... **Responsibilities:** + Responsible for design and execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity.… more
    Lilly (07/23/25)
    - Related Jobs

  • Director, Quality - Digital Systems

    ThermoFisher Scientific (Indianapolis, IN)
    …systems. + Coordinate all aspects of the company's Computer System Validation ( CSV ) and global IT activities supporting cGMP processes within the division. + ... plans, and lead project results to support the growing CSV needs of the business, improving and optimizing the...partners. + Develop, revise, and implement QA IT and CSV policies and procedures to ensure global harmonization and… more
    ThermoFisher Scientific (07/12/25)
    - Related Jobs

  • Idap MES System Engineer Tech@Lilly

    Lilly (Indianapolis, IN)
    …hypercare support and frontline troubleshooting. + Ensure compliance with Computer System Validation ( CSV ) standards, including 21 CFR Part 11 and GAMP 5. + Develop ... + Working knowledge of cGMP and Computer System Validation ( CSV ) frameworks + Ability to interpret process requirements and...+ Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 CFR Part 11,… more
    Lilly (07/30/25)
    - Related Jobs

  • Process Engineer - Formulation

    Novo Nordisk (Bloomington, IN)
    …execute, and approve protocols and reports related to Automation System Validation ( CSV ). This includes deviation reporting during execution + Act as primary Subject ... Matter Expert (SME) for CSV + Assist and manage production and laboratory system contractors as required + Review and approve changes to computerized automation… more
    Novo Nordisk (07/30/25)
    - Related Jobs

  • Automation Engineer - Global Serialization Program

    Lilly (Indianapolis, IN)
    …+ Experience with Good Manufacturing Practices (GMP) and Computer System Validation ( CSV ) regulations, will be vital in ensuring documented processes and procedures ... processes and equipment + 2+ years experience in GMPs and computer systems validation ( CSV ) Additional Information: + Must be able to travel up to 25% of the… more
    Lilly (07/11/25)
    - Related Jobs

  • Senior Engineer, Facilities & Maintenance CLT

    Novo Nordisk (Bloomington, IN)
    …key Subject Matter Expert (SME) for automation design, systems integration and CSV (Automation Only) + Apply and enhance existing automation validation methods and ... and approve protocols and summary reports related to Automation System Validation ( CSV ).. + Review and approve changes to computerized automation production and… more
    Novo Nordisk (06/30/25)
    - Related Jobs

  • Sr Lead Big Data Developer

    Lumen (Indianapolis, IN)
    …from various sources and formats, such as relational databases, APIs, JSON, XML, CSV , etc. + Perform data quality checks and validations, and handle data anomalies ... and issues + Collaborate with other developers, data engineers, data analysts, and business stakeholders to understand data requirements and deliver data solutions + Develop scalable systems that enable real-time validation of identified resources + Mentor… more
    Lumen (08/08/25)
    - Related Jobs

  • Advisor/Sr. Advisor - Inspection Lead

    Lilly (Indianapolis, IN)
    …EMA). + Strong knowledge of GxP regulations, computer system validation ( CSV ), and quality management systems. **Additional Preferences:** + Understanding of process ... development and/or improvement (eg Six Sigma) + Familiarity with IT Best Practices (eg, LSEF, ITIL, NIST) + Excellent communication, facilitation, and stakeholder engagement skills. + Demonstrated ability to lead cross-functional initiatives and influence… more
    Lilly (08/04/25)
    - Related Jobs

  • Senior Manager, IT - GxP Computer Systems…

    Bristol Myers Squibb (Indianapolis, IN)
    …matters, and defends their work before regulatory agencies and auditors. + Provides CSV expertise and guidance. + Responsible for compliance with local and global ... SOPs during qualification. + Audit and Operational readiness for site. + Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. + Change Management… more
    Bristol Myers Squibb (08/03/25)
    - Related Jobs

  • Director Laboratory Informatics Lilly Medicine…

    Lilly (Lebanon, IN)
    …solutions; Consult with other System Owners, customers, and business partners regarding CSQ/ CSV requirements and business integration. + Work with business SMEs and ... stakeholders to define, develop, and implement business processes to help ensure effective use of lab informatics solutions; Refine business requirements in collaboration with SMEs and stake holders. + Represent business requirements in vendor discussions. +… more
    Lilly (08/03/25)
    - Related Jobs