- Lilly (Indianapolis, IN)
- …**Regulatory Compliance:** + Ensure adherence to current regulatory requirements, including cGMP standards, ISO 14971, ISO 11608, OSHA regulations, and environmental ... sustainability goals. + Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. + Identify weaknesses and opportunities in control strategy and pursue improvements and resolution. +… more
- Lilly (Indianapolis, IN)
- …test methods and validation reports for completeness and adherence to cGMP standards; 3 years of experience planning, conducting, and interpreting experiments ... and experimental data in a laboratory environment; 3 years of experience preparing Standard Operating Procedures for quality control analysis for pharmaceutical or biotechnology products; and 3 years of experience validating analytical test methods and… more
- Lilly (Indianapolis, IN)
- …of 3 years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation. + Relevant industrial experience in any of ... the following disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Regulatory, Development, or Administration. **Additional Skills/ Preferences:** + Has experience in Statistical Process Control (SPC) and Six… more
- Lilly (Indianapolis, IN)
- …Compliance:** + Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. + Support ... site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. **Process Optimization:** + Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for… more
- Novo Nordisk (Bloomington, IN)
- …data integrity and ensure compliance with company SOP's, specifications, as well as cGMP , ICH, FDA, EMA regulations or guidelines o Able to combine and interpret ... data from multiple disciplines and has a commanding understanding of the full Biologics process o Well organized with ability to handle and direct multiple activities across departments simultaneously . Behavioral Requirements o Shares own ideas in a… more
- Lilly (Indianapolis, IN)
- …in Project Delivery, Commissioning & Qualification, Validation Activities, and cGMP Regulations + Experience in control system troubleshooting, programming, and ... integration with PLC (Rockwell Studio5000), HMI/SCADA (FactoryTalk View Studio SE), Fanuc Robotics, 3DV, and Cognex vision systems. **Additional Skills/Preferences:** + Knowledge in AutoCAD and SolidWorks + Proven ability to communicate effectively to… more
- Lilly (Indianapolis, IN)
- …in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. **Key Objectives/Deliverables:** + Lead/ provide ... support to launch new products/ packages/ CMs + Participate on Joint Process Teams + Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations. + Levelling,… more
- Lilly (Indianapolis, IN)
- …systems **What We Value in You:** + Depth knowledge of regulatory compliance ( cGMP ). + Proven leadership prowess and team-building excellence + Agile management of ... simultaneous projects, with a knack for adapting to shifting priorities. + Collaborative spirit with cross-functional teams. + Exceptional communication skills, both written and verbal. + A creative and analytical mindset, equipped to resolve complex issues. +… more
- Jacobs (Indianapolis, IN)
- …pharmaceutical and life sciences meeting standards for current Good Manufacturing Practice ( cGMP ) applications and other process related facilities. If you're up for ... the challenge, we've been looking for someone just like you, join our team and help us lay the foundation for human progress. * A Bachelor of Science Degree in Mechanical Engineering (or other engineering degree) * 8+ years of Mechanical Engineering Experience… more