- Novo Nordisk (Bloomington, IN)
- …6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee ... deliverables with cross-functional team (eg, PMO, Process Development, Manufacturing, Validation , Engineering, Quality Assurance, etc.) to maintain project timelines… more
- Lilly (Indianapolis, IN)
- …inspection processes, including associated defect classification, control strategies, validation strategies, and personnel qualification strategies. The Associate ... audits + Technical review and approval for site quality documents, plans, validation related documents, and technical studies. + Define strategic direction and… more
- Lilly (Indianapolis, IN)
- …reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes. + Independently identify ... procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. **Minimum… more
- Lilly (Lebanon, IN)
- …the initial start-up of the manufacturing areas as well as post Process Validation support. Manufacturing Execution System (MES) Expertise: + High level of expertise ... decision-making skills, complex problem-solving abilities. + Strong knowledge of pharmaceutical manufacturing processes, facility start-up procedures, and GMP regulations.… more
- Lilly (Lebanon, IN)
- …constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's ... in and support training and engineering runs. + Responsible for supporting validation activities and ensuring GMP production areas are within compliance. + Support… more
- Lilly (Indianapolis, IN)
- …manufacturing batch records. + Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug ... drug product and radioisotopes. + Participate in technical transfer and process validation activities in collaboration with other departments. + Safely work with… more
- Lilly (Indianapolis, IN)
- …process variability and capability. + Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to ... required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process… more
- Lilly (Indianapolis, IN)
- …alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations and termination. DPEM Quality Assurance is ... and monitor Quality metrics for trends at the CM + Support Qualifications/ Validation document creation and reviews + Provide and coordinate designated sections for… more
- Lilly (Indianapolis, IN)
- …approval of date extension requests and due date changes, approval of process validation protocols and reports, approval of validation master plans, approval of ... risk-based rationale if bracketing of products is used for cleaning validation , etc.) + Ensure adequate quality oversight for manufacturing operations within their… more
- Novo Nordisk (Bloomington, IN)
- …6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee ... solutions + Coordinating tasks with supporting groups (Quality, MS&T, Validation , Maintenance, etc) + Support Maintenance/Engineering teams during repairs/upgrades +… more