- Fujifilm (Holly Springs, NC)
- …transfer (TT) across multiple unit operation + Coordinates, plans, and executes manufacturing process validation runs + Supports design and leads generation of ... sampling plans for process validation reports (PVRs) and investigations + Writes and reviews master batch records (MBRs) and standard operating procedures… more
- Lilly (Concord, NC)
- …on the delivery of parenteral operations, specifically regarding technical transfer and process validation . TSMS PAR Scientist will support the formulation, ... ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation… more
- Honeywell (Raleigh, NC)
- …Specifications, Data Mapping, Approval of Functional specification / Data mapping, Validation process , Actual Validation completion, Progress Approvals ... data cleansing and support documentation. + Help define data validation requirements and document the process for...define data validation requirements and document the process for validation using various data extraction… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …for technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… more
- Lilly (Durham, NC)
- …Provide technical support for start-up activities in particular technology transfer and process validation . + Author, review, approve and provide technical ... an accurate instruction set (manufacturing batch records & procedures) describes the process as performed and the control strategy for the discrete manufacturing… more
- ThermoFisher Scientific (Greenville, NC)
- …is preferred. + Strong understanding of GMP, regulatory compliance, and process validation requirements. + Demonstrated capability in coordinating complex ... with analytical, quality, and project management teams to drive successful process development and commercialization. Experience with data science or statistical… more
- Pfizer (Sanford, NC)
- …confirm Critical and Key Process Parameters essential for Equipment and Process Validation . + General knowledge of scientific principles, technical knowledge ... Have** (Preferred Requirements) + Experience in automation including DeltaV and equipment validation + Knowledge of the manufacturing process and equipment,… more
- ThermoFisher Scientific (Greenville, NC)
- …immediate and controlled-release dosage forms. + In-depth knowledge of GMP, process validation , and regulatory requirements. + Strong problem-solving, ... data science or statistical analysis tools (eg, Python, MATLAB) to support process development and optimization is highly desirable. Your expertise will be essential… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and… more
- Lilly (Durham, NC)
- …experience with highly automated equipment + Previous equipment qualification and process validation experience. + Previous experience with Manufacturing ... staffing, training, and leadership of the operations group supporting asset delivery, process development, operational readiness, start up, and validation of the… more