- Lilly (Lebanon, IN)
- …for pharmaceutical manufacturing. + Solid knowledge of Computer System Validation process . + Excellent problem-solving skills to address complex IT ... a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API) to meet needs for an expanding...and vice versa. + Produce and maintain project and validation documentation. + Ensure systems remain in a validated… more
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... all in-scope applications, ensuring all system activities meet requirements for validation , change control, documentation, audit trails, and data integrity. +… more
- Lilly (Lebanon, IN)
- …routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global ... regulatory manufacturing guidance, and the corporate/industry standards for validation . The Sr. Dir. - QC will work cross-functionally within the site, network,… more
- Cardinal Health (Indianapolis, IN)
- …Must have experience with equipment qualification, software validation , test method validation , and/or process validation preferred. + Has experience in ... Deviations (Nonconformance), and Laboratory Investigations preferred. + Must understand the validation and technology transfer process and have experience with… more
- Lilly (Indianapolis, IN)
- …support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and ... a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process … more
- Lilly (Indianapolis, IN)
- …assembly and packaging processes. You'll ensure robust design, integration, and validation aligned to global standards while meeting site-specific needs. **How ... Exception, Recipe Management, Equipment Management, and EBR authoring. + Support validation activities including authoring/reviewing of design specs, test plans, and… more
- Lilly (Lebanon, IN)
- …technical documents supporting process control strategies, technology transfers, process validation , deviation/adverse event reporting, process ... audits. + As required, may lead or assist in the planning and execution of process validation activities. + As required, may own or assist in the implementation… more
- Lilly (Indianapolis, IN)
- …and their impact to the medical device design transfer and post-launch surveillance process . + Engage externally to ensure the organization stays current in the ... reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes. + Independently identify… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of ... electronic quality systems (eg, TrackWise), including configuration, training, and validation . + Cross-Functional Collaboration: Partner with regional quality leaders,… more
- Cardinal Health (Indianapolis, IN)
- …and thorough inspections and analysis of incoming materials, Drug Substance, In- Process and Drug Product samples. + Performs investigations, deviations, change ... controls and CAPAs. + Execute method verification, validation and/or transfer protocols. + Perform stability testing in...21 CFR 210, 211 in the FDA regulated industry ( Pharmaceutical or Medical Device) preferred. + Has general knowledge… more
Recent Jobs
-
Senior Financial Analyst, Design & Construction, Gref FP&A
- Amazon (Arlington, VA)
-
Automated Trading Strategies - Associate
- JPMorgan Chase (New York, NY)
-
Mechanical Project Manager
- Johnson, Mirmiran, and Thompson Inc. (Newark, DE)