- Novo Nordisk (Bloomington, IN)
- …cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation , environmental testing, and investigations, preferred ... is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product… more
- Lilly (Indianapolis, IN)
- …of the sterility assurance programs. The scope of responsibilities includes aseptic process support, EMPQ, Sterilization Validation , Aseptic Process ... and studies. + Use sterility assurance risk management to evaluate existing process and controls with respect to microbial, endotoxin and particulate contamination… more
- Lilly (Indianapolis, IN)
- …technical support for equipment in the Global Robotics Lab. + Work with site process teams to support the investigation and resolution of issues pertaining to GRP ... to travel up to 75% + Minimum 3 years of front-line GMP pharmaceutical manufacturing experience. + Strong mechanical aptitude and experience with mechanical design.… more
- Lilly (Indianapolis, IN)
- …for the development and delivery of programs for continuous process optimization and improvement. **Key Objectives/Deliverables:** + Understand the scientific ... technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, and/or productivity. + Provide technical support for… more
- Lilly (Indianapolis, IN)
- …detail-oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and ... the internal and external manufacturing network. **Technical Expertise & Process Optimization** : + Serve as the go-to expert...Q standards, Common Q practices, ) and execution documents ( validation reports, PoDs ) to support the visual inspection… more
- Lilly (Lebanon, IN)
- …for pharmaceutical manufacturing. + Solid knowledge of Computer System Validation process + Must have Excellent communication skills + Demonstrated ... Qualify the MES solution for the Facility. You will also partner with the process automation, site operations area and global Tech at Lilly teams to determine… more
- Lilly (Indianapolis, IN)
- …to device testing for commercial and development product (eg, design verification, process validation , stability, and batch release testing). + Support Event ... validation , and device testing. + Participate in departmental process improvement activities (continuous improvement). + Participate in regulatory agency and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …objectives to business partners. + Partnering with end-to-end with business process owners, technical solution owners, engineers, and analysts to understand ... Profound grasp of Machine Learning lifecycle - feature engineering, training, validation , scaling, deployment, scoring, monitoring, and feedback loop. + Have… more
- Cardinal Health (Indianapolis, IN)
- …in- process , and product samples. + Executes method verification, validation , and/or transfer protocols, analytical equipment qualification protocols, or computer ... and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback. + Reports errors...system validation test scripts, as needed. + Performs stability testing… more
- Lilly (Indianapolis, IN)
- …years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical , biotech, CRO or regulatory ... 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