- 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
- 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
- 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
- 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
- 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
- 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
- Lilly (Indianapolis, 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 (Indianapolis, IN)
- …preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 CFR Part 11, Annex 11). + ... Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. + Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. + Ability to work… more
- Novo Nordisk (Bloomington, IN)
- …execute, and approve protocols and reports related to Automation System Validation ( CSV ). This includes deviation reporting during execution + Assist and manage ... production and laboratory system contractors as required + Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems + Assist in responding to… more
- 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