- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of ... electronic quality systems (eg, TrackWise), including configuration, training, and validation . + Cross-Functional Collaboration: Partner with regional quality leaders,… more
- Amgen (New Albany, OH)
- …technologies into existing manufacturing and packaging systems. + Support process characterization, optimization, and performance monitoring to improve throughput, ... execute system upgrades, obsolescence mitigation, and reliability improvements. **Compliance, Validation , and Quality Assurance** + Ensure systems operate in… more
- Cardinal Health (Indianapolis, IN)
- …and thorough inspections and analysis of incoming materials, Drug Substance, In- Process and Drug Product samples. + Performs investigations, deviations, change ... controls and CAPAs. + Execute method verification, validation and/or transfer protocols. + Perform stability testing in...21 CFR 210, 211 in the FDA regulated industry ( Pharmaceutical or Medical Device) preferred. + Has general knowledge… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …development of risk assessments and test methods + Leads component qualifications, design validation / verification and process validation + Leads product ... and risk assessment techniques + Working knowledge of test method (development and validation ), equipment qualifications, process and design validation , risk… more
- LSI Solutions (Victor, NY)
- …recommendations for improvements. + Lead in the selection, installation, and validation of medical device process /packaging equipment utilizing project ... $128,000 JOB SUMMARY: The Production Engineer is responsible for manufacturing process development, production transfer, product and problem diagnosis and repair.… more
- AbbVie (North Chicago, IL)
- …agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by ... plants for further packaging and/or testing. Drives implementation of the Product Transfer Process from R&D to AbbVie sites. + Supports the management of exception… more
- Gilead Sciences, Inc. (Foster City, CA)
- …is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). The preferred candidate will have ... and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s) +… more
- Sutter Health (Palo Alto, CA)
- …PAMF-Palo Alto Medical Foundation PAD **Position Overview:** Delivers pharmaceutical care through the provision of patient-centered clinical service, ... evidence-based medication use and education to the same. + Supports process improvement efforts, and educates co-workers around medication reconciliation, medication… more
- BeOne Medicines (Pennington, NJ)
- …Manager requires rich technical experience in construction project management for pharmaceutical production facility and ability to manage projects and ensure ... highly desirable. + Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding… more
- Amgen (New Albany, OH)
- …changes. + Interact with the FDA. + Ensure Amgen policies are followed ** Process /Equipment/Facilities:** + Ensure maintenance and re validation of systems. + ... degree **Or** Master's degree and 3 years of experience in the pharmaceutical , medical device or biotechnology industry **Or** Bachelor's degree and 5 years… more
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