- Cook Medical (Ellettsville, IN)
- …Facilitate development and implementation of production controls (eg qualification, process capability, sampling plans, validation , etc.)* Perform investigation ... of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues* Plan, review, and approve… more
- Lilly (Indianapolis, IN)
- …of drug products and radioisotopes. + Participate in technical transfer and process validation activities in collaboration with other departments. + Safely ... ensure proper function and compliance with the established calibration / PM equipment schedule. + Continuous process improvement of existing manufacturing… more
- Lilly (Indianapolis, IN)
- …+ Occasional travel may be required to support business needs. + Previous equipment qualification and process validation experience. + Previous experience ... + **Technical Excellence:** Lead and provide technical and effective process support services for production issue resolution and investigations, ensuring… more
- Cook Medical (Bloomington, IN)
- …technical requirements to non-technical stakeholders* Demonstrated use of process mapping, diagramming, user scenarios, and writing testable requirements* ... * Deliver appropriate requirements documentation in accordance with software validation procedures and processes* Must have highly collaborative approach to… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …for technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… more
- Lilly (Indianapolis, IN)
- …of the organization for decisions, influencing, coaching and mentoring. + Previous equipment qualification and process validation experience. + Previous ... procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. 4.… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Eli Lilly Clinical Diagnostics Laboratory** ** Medical Laboratory Scientist** **Job Description** **Purpose of the Job:** The Eli ... bodies. Data generated might also be utilized to support regulatory submissions. The Medical Laboratory Scientist (MLS) or Medical Technologist (MT) role in the… more
- Novo Nordisk (Bloomington, IN)
- …of agreements + Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (eg, PPQ, CPV, APR / ... cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation , environmental testing, and investigations, preferred… more
- Lilly (Lebanon, IN)
- …+ An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation , On-going Process Verification. ... Execution. The ideal candidate will possess strong influencing capabilities as well as process knowledge and process improvement skills. In this role, you will… more
- Lilly (Lebanon, IN)
- …the ground up. The TS/MS team will own all areas of technology transfer, process validation , and process stewardship. **Job Description** Sterility Assurance ... collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the… more