- 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
- Lilly (Indianapolis, IN)
- …their assigned functional areas, projects and/or systems comply with corporate computer system validation ( CSV ) standards. This includes providing ... Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per...systems development life cycle + Proficiency with Lilly Computer Systems Validation and demonstrated… more
- Lilly (Indianapolis, IN)
- …their assigned functional areas, projects and/or systems comply with corporate computer system validation ( CSV ) standards. This includes providing ... Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per...+ Proficiency with Microsoft Office products + Experience with Computer Systems Validation + Prior… 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
- PACIV (Indianapolis, IN)
- …protocols, and final reports. + Proficient in Commissioning & Qualification (C&Q) and/or Computer System Validation ( CSV ), with a solid understanding of ... and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments. Join our Indianapolis, IN team… more
- Lilly (Indianapolis, IN)
- …technical guidance and leadership with non-conformance investigations, construction, equipment and computer systems design and validation , change control ... Engineer - Facility, Utilities, HVAC, and Equipment (FUME) & Computer Systems Quality (CSQ) QA is a...Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation ( CSV ) of… more
- Lilly (Indianapolis, IN)
- …Servers, Network and Infrastructure and applications + Support the Process Control Validation Plan, CSV , Quality Documents, SOP's and Audit Readiness + ... a system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems + Working experience administering… more
- Lilly (Indianapolis, IN)
- …efforts, including hypercare support and frontline troubleshooting. + Ensure compliance with Computer System Validation ( CSV ) standards, including 21 CFR ... is ideal for someone who is passionate about technology, systems thinking, and supporting frontline manufacturing teams. **What You'll...or packaging operations. + Working knowledge of cGMP and Computer System Validation ( CSV ) frameworks… more