- Lilly (Indianapolis, IN)
- …responsibility for ensuring all products are manufactured according to a validated process , following the approved control strategy and maintaining in a validated ... to ensure reliable supply of medicines through effective and efficient manufacturing process . + Ensure capable and in control processes at CMs. Establish and… more
- Lilly (Lebanon, IN)
- …support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and ... a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process … more
- PACIV (Indianapolis, IN)
- PACIV stands for Process Automation, Controls, Instrumentation, and Validation . At PACIV, we are passionate about delivering world-class automation & ... validation solutions that empower many industries and advanced manufacturing....process instrumentation for capital projects, particularly within the pharmaceutical sector. Managing all aspects of instrumentation logistics, procurement,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …role will also involve advanced laboratory analyses, troubleshooting efforts, method validation and qualifications ensuring compliance with regulatory and QA system ... and media qualification testing. + Execute method qualification, verification and validation studies with minimal supervision. + Troubleshoot assay related issues… more
- Bristol Myers Squibb (Indianapolis, IN)
- …manner. + Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, validation /verifications and equipment qualifications. + ... EM technologies and improve data visibility. + Identify other opportunities for process improvements and implement changes to increase quality and efficiency within… more
- Lilly (Indianapolis, IN)
- …a fast-paced, dynamic, and highly collaborative environment. + Experience with process validation , technology transfer, and regulatory filings (IND/NDA/BLA) is ... robust and compliant manufacturing of peptide drug substances, from process development through commercialization and life cycle management. **Job Responsibilities**… more
- Lilly (Lebanon, IN)
- …of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be...or engineering field) + 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles + Previous… more
- Lilly (Indianapolis, IN)
- …of drug product and radioisotopes. + Participate in technical transfer and process validation activities in collaboration with other departments. + Safely ... Control to resolve quality events and support on-time product release + Support process development, technical transfer, and validation activities for new or… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …corporate quality objectives. The position drives governance, technology enablement, and process optimization for training systems and programs across GxP and ... experience and compliance tracking. + Ensure data integrity and system validation in accordance with GxP requirements. **Operational Excellence** + Lead global… more
- Lilly (Indianapolis, IN)
- …American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... launch new products/ packages/ CMs + Participate on Joint Process Teams + Understand Lily global quality systems and...metrics for trends at the CM + Support Qualifications/ Validation document creation and reviews + Provide and coordinate… more