- Novo Nordisk (Bloomington, IN)
- …audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for ... equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance… more
- Lilly (Indianapolis, IN)
- …serialization strategy for packaging. + Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations, will be vital in ... + Familiarity with industry standards such as GS1 and FDA DSCSA regulations, System integration with enterprise...and equipment + 2+ years experience in GMPs and computer systems validation (CSV) Additional… more
- Lilly (Indianapolis, IN)
- …or more years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or ... and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid… more
- Lilly (Indianapolis, IN)
- …exceptional IT support to end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver ... will utilize the latest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact to our environment.… more
- Lilly (Indianapolis, IN)
- …and team related skills required. + Experience with various assay platforms and computer software applications including LIS systems . + Bench level experience in ... Technologist (MT) role in the ELCDL is responsible for specimen handling ( validation , triaging, storage) and analysis of human biological samples using different… more
- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
- Novo Nordisk (Bloomington, IN)
- …Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech transfers of new ... products + Support and review process and engineering validation work + Investigate deviations + Speak with clients,...pharmaceutical products + Knowledgeable in technical guidance documents from FDA , EMA, PDA, ISPE, ICH, ISO, PIC/S and other… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically ... Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing + Support review and… more
- Trane Technologies (Noblesville, IN)
- …understand work instructions in English. Certifications / Licenses: None required. Computer Systems / Software: MRP/ERP preferred Specialized Training: Wiring ... performance of temperature controlled storage units,, refrigerators/freezers and thawing systems . Cross-trained to perform specialty functions. On a regular basis,… more
- Lilly (Indianapolis, IN)
- …packaging processes and equipment + 1+ years of experience in GMPs and computer systems validation (CSV) **Additional Skills/Preferences:** + Experience in ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP,… more