- 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 (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 (Lebanon, 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
- 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
- Cognizant (Indianapolis, IN)
- …Strong understanding of GMPs, regulatory compliance, and computer system validation ( CSV ) principles. . Excellent communication skills, with the ability to influence ... stakeholders at all levels. . Experience in mentoring and developing junior engineers and technical leads. . Ability to manage multiple priorities and stakeholders in a dynamic project environment. **SKILLS** . Strategic thinker with a proactive and… more
- Lilly (Indianapolis, IN)
- …UV Vis, Humidity, etc.). + Familiarity with Calibration System IQ, OQ and Software CSV and ability to install and qualify systems to meet customer user requirements. ... + Knowledge of NIST and NCSLI practices and procedures. + Knowledge of ISO17025 and Lab Accreditation processes. + Pharmaceutical, biotech, food, or specialty chemical industry experience preferred. + Demonstrated ability to perform engineering math functions.… 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