- Roche (Indianapolis, IN)
- …in the development of new standards and the revision of existing standards related to Computer Systems Validation ( CSV ). + Assemble global feedback on ... systems and services adhere to regulatory standards (eg, CSV , GMP, GCP) and regulatory risks are managed adequately...systems (and some business domains) with regard to Computer Systems Validation and other… more
- Cardinal Health (Indianapolis, IN)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… more
- Lilly (Indianapolis, IN)
- …efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation ( CSV ) of GMP assets including review and ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Lilly (Lebanon, IN)
- … Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + ... will provide CSV support leading and executing CSV activities for process automation systems across...and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum… more
- PACIV (Indianapolis, IN)
- …completion action items for any deficiencies resulting from Periodic Reviews. + Update Computer System Validation ( CSV ) documentation which may include ... environment. This role is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items to completion.. The… more
- Lilly (Lebanon, IN)
- … in the pharmaceutical industry **Additional Preferences:** + Direct experience with Computer Systems Validation (GAMP5) and data integrity basic ... applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and… more
- Alight (IN)
- …& AWS + Linux Server Commands and Management + Data Formats: JSON, XML, CSV + Mainframe systems , commands and utilities + JCL **Years of Experience:** ... work across multiple platforms-including Quadient , SmartComm, and mainframe systems -to support, customize, and improve client-facing print and electronic… more
- Lilly (Indianapolis, IN)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 ... will apply the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact to our environment.… more
- Cardinal Health (Indianapolis, IN)
- …Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/ CSV ( Computer System Validation ), DSCSA(Drug Supply Chain ... products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician offices… more