- Lilly (Indianapolis, IN)
- …Stewardship: Support projects to improve assembly equipment design. + Tool and Process Validations: Create, execute, and coordinate validation activities with ... custom automated assembly equipment utilized as part of the manufacturing process . These equipment deliveries support new product launches, capacity expansions and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
- Novo Nordisk (Bloomington, IN)
- …systems + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities ... 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
- Novo Nordisk (Bloomington, IN)
- …systems + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities ... 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)
- …capabilities (eg nitrosamine, conjugatable impurities). + Demonstrated registration stability, process validation , or post-approval process development ... Overview:** Bioproduct Research and Development (BRD) is the large-molecule process development organization within Lilly. BRD is responsible for material… more
- Lilly (Indianapolis, IN)
- …being flexible, proactive and involved. Serve as a responsible engineer for site process lines by possessing a deep knowledge of equipment and unit operation design ... impact on the safety or quality integrity of the equipment or process . **Innovation and Problem-Solving:** + Provide equipment and processing support for production… more
- Novo Nordisk (Bloomington, IN)
- …Supervisor. Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech ... family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability...transfers of new products + Support and review process and engineering validation work + Investigate… more
- Novo Nordisk (Bloomington, IN)
- …well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities. + Essential Functions + This role will ... 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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management ... performance, identify trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for upstream processes… more
- Lilly (Lebanon, IN)
- …and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges. ... and implement the appropriate technical solutions. + Ensure project and/or validation documentation is maintained during lifecycle & release management. + Evaluate… more