- Lilly (Lebanon, IN)
- …support the start-up and validation of new facilities and the associated process equipment . Helps to define and implement control strategies for Lilly ... technical reports supporting process control strategies, technology transfers, process validation , deviation/adverse event reporting, process … more
- Lilly (Indianapolis, IN)
- …testing effort. + Perform Software Code Reviews and manage the Software Configuration Management Process for the equipment . + Develop a deep understanding of the ... people around the world. **What You'll Be Doing** The Engineer - Automation/ Process Serialization is accountable for the direct support throughout the design, build,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …operations such as sample management, testing, and data review, method development, validation , and transfer, equipment validation , and associated projects. ... laboratory investigations, deviations, corrective or preventative actions, method development, validation , and transfer activities, equipment validation … more
- Lilly (Indianapolis, IN)
- …or related technical roles + Familiarity with or experience in validation practices, including equipment commissioning, qualification, or computer system ... ownership for two critical digital systems: **Kneat** , used for managing validation and compliance documentation, and **Batascript,** used to track and document fit… more
- Cook Medical (Bloomington, IN)
- …projects including process optimization , reliability testing , and method validation + Strong knowledge of medical device regulations (ISO 13485, 21 ... Overview Cook Medical is seeking a highly skilled and experienced...(ISO 14971) with experience in statistical sampling plans and process validation + Proficiency in statistical software… more
- Cook Medical (Bloomington, IN)
- …This includes supporting product design, verification testing, regulatory compliance, process validation and manufacturing line establishment. A Packaging ... Overview The Packaging Engineer 2 uses their experienced in medical device packaging to design and develop solutions for...time lines and critical deliverables. + Ensure compliance of equipment and packaging designs with company quality system. +… more
- Cardinal Health (Indianapolis, IN)
- …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)
- …Main support functions include specifying and purchasing equipment ; authoring Equipment Qualification (EQ) and Computer System Validation (CSV) packages, ... and local procedures in the development of qualification / validation protocols and equipment lifecycle management. +...to request an accommodation as part of the application process and any other correspondence will not receive a… more
- Cook Medical (Bloomington, IN)
- …and assurance of sterility requirements. Responsibilities * Collaborate and approve product/ process changes to ensure sterilization validation remains compliant. ... multiple projects/tasks related to ensuring continued compliance with sterilization validation and product adoption requirements. The Sterility Assurance Specialist… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …CFR 820 required + Prior experience with medical qualification and validation protocols for equipment , systems, processes and products strongly preferred ... Lean, Six Sigma, and risk management tools to monitor and drive process improvement activities. + Works collaboratively with manufacturing and biomedical leadership… more