- GRAIL (Indianapolis, IN)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- Sumitomo Pharma (Indianapolis, IN)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- Insight Global (Indianapolis, IN)
- …Qualification, Validation ) or IQ OQ PQs protocols within an FDA regulated environment for their pharmaceutical customer. Pharma experience is not required ... have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment process,… more
- Oracle (Indianapolis, IN)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Lilly (Indianapolis, IN)
- …+ Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and ... direction and standards. + Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance. + Experience… more
- PACIV (Indianapolis, IN)
- …Working knowledge of Data Historian systems, particularly OSI PI. + Understanding of Computer System Validation lifecycle and FDA regulatory requirements. + ... systems to enhance reliability, compliance, and performance. + Collaborate with the Validation Team to ensure automation systems align with regulatory and quality… more
- GRAIL (Indianapolis, IN)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- Fujifilm (Indianapolis, IN)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Lilly (Lebanon, IN)
- …upgrades/patching of hardware and software applications. + Providing supporting documentation for validation and testing of upgrades + Drive the validation of ... to assure GMP data integrity Your Minimum Requirements: + Bachelor's degree in computer science, Information Technology or related technical field + Minimum 4+ years… more
- Trane Technologies (Noblesville, IN)
- …or more of the following: . Unit preparation . Unit start up procedures and validation . Unit shut down procedures and validation . Wiring and electrical ... needed. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established procedures and… more
