- Lilly (Indianapolis, IN)
- …TN status) for this employment position._ **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, ... 21 CFR Part 11, Annex 11). + Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. + Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. +… more
- Lilly (Indianapolis, IN)
- …while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, ... regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. + **Performance Metrics:** Develop and communicate department metrics to drive continuous improvement and ensure alignment to business goals. Develop team goals for safety,… more
- Lilly (Indianapolis, IN)
- …a lesser extent, lab projects.** **Experience in the following areas: GMP manufacturing, LEAN, automation, construction, construction quality, project controls, the ... engineering disciplines, safety, and scheduling.** **The capacity to achieve results and influence through people.** **Demonstrated ability to work from long distances with little supervision.** **Must exhibit a good sense of judgment in decision making,… more
- Lilly (Indianapolis, IN)
- …always within the organization. + Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, change controls, ... regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. **Minimum Qualifications:** + Bachelor's degree in Science, Engineering, or related field. + 5+ years of experience in pharmaceutical and/or medical device manufacturing or… more
- Lilly (Indianapolis, IN)
- …distribution field + A minimum of 2 years of work experience in GMP regulated pharmaceutical and/or medical device industries is required. + Background in sterile ... barrier and/or deep frozen product packaging **Additional Skills/Preferences:** + Strong technical problem solving with emphasis on patient/consumer-centered design, package functionality, and manufacturability + Broad integrated technical knowledge for system… more
- Lilly (Indianapolis, IN)
- …PFDs, etc. + Remain current with all the regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations) + Provide ... support to internal and joint process teams. **Basic Qualifications:** + Bachelor's Degree in scientific disciplines of Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry,… more
- Lilly (Indianapolis, IN)
- …always within the organization. + Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, ... change controls, validation protocols and summary reports, etc. **Minimum Qualifications:** + Bachelor's Degree in Engineering, Science or related field. + 5+ years' experience in pharmaceutical manufacturing or regulated industry. + In-depth knowledge of… more
- Lilly (Indianapolis, IN)
- …equipment specifications, performing equipment testing and qualification, and maintaining GMP readiness. Part time telecommuting may be permitted. 25% domestic ... and international travel required. #LI-DNI JOB LOCATION: Indianapolis, IN To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-88219 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to:… more
- Lilly (Lebanon, IN)
- …to build the processes and facility to enable a successful startup into GMP manufacturing operations._ _We are seeking Senior Principal Process Engineers to support ... the API Manufacturing Business in Lebanon. Process Engineering is core to delivering our product pipeline across batch and continuous API production and development._ **Responsibilities** The Senior Principal Process Engineer provides technical leadership and… more
- Lilly (Indianapolis, IN)
- …The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities. + The designation and monitoring of storage ... conditions for materials and products. + The retention of records. + The monitoring of compliance with the requirements of Good Manufacturing Practice. + The inspection, investigation, and taking of samples, in order to monitor factors which may affect product… more