Chemical Process Quality Engineering Specialist-LosAngelesHelpWantedcom-Irvine,CA,California-Process Engineering Jobs
B
Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company s Sharing Expertise® philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives |-| |-| Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B
Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals
For more information, call 800-227-2862, e-mail us at inquiry
us@bbraun
com or visit B
Braun at www
bbraunusa
com
|-| |-| We are currently seeking a Chemical Process Quality Engineering Specialist (job #1183)
|-| |-| Job Purpose: |-| |-| * Responsible for the overall Chemical Quality Control and Assurance Program for a new manufacturing facility for Sterile IV solutions
|-| |-| * Responsible to ensure compliance with US FDA requirements for the design, validation, and control of drug chemical manufacturing facilities, equipment, and processes for sterile, injectable Pharmaceutical products
|-| |-| Essential Job Functions: |-| |-| Equipment Specification and Design Review: |-| |-| * Provide expert input and critical review of designs and specifications for Chemical processing equipment, piping, instrumentation, and control systems
|-| |-| * Provide Quality Assurance approvals for Specification, Design Review, and Risk Assessment documentation
|-| |-| Process Development: |-| |-| * Provide expert leadership and guidance in Chemical manufacturing process development, technology transfer, scale-up, and optimization, to include highly-automated batch formulation and CIP/SIP systems
|-| |-| Process Quality Control: |-| |-| * Responsible to develop and specify equipment, instrumentation, procedures, and in-process test methods for Quality Control, including PAT applications
|-| |-| * Define requirements for Chemical Process SCADA and data exchange with MES, LIMS, EBR, and ERP systems for process control, laboratory testing, and final product release
|-| |-| Commissioning Qualification and Validation: |-| |-| * Interface with Engineering and Validation to coordinate Chemical equipment, process, instruments, and method validation
|-| |-| * Responsible to define and to administer the Chemical process cleaning validation program
|-| |-| Material and Supplier Qualification: |-| |-| * Responsible to administer the Chemical Material Supplier Qualification program for drug substances, excipients, and container/closure materials
|-| |-| * Responsible to define Incoming material test programs and Supplier CofA requirements
|-| |-| Stability / Registration / Regulatory Submissions: |-| |-| * Responsible to supervise execution of Stability / Registration batch protocols and to coordinate laboratory testing, data analysis, and reporting
|-| |-| * Responsible to provide technical input to A/NDA CMC submissions
|-| Represent the Company Chemical QA program in contacts with Regulatory Agencies and in Pre-Approval Inspection
|-| |-| Operations Planning and Start-Up: |-| |-| * Responsible to define Laboratory facilities, instrumentation, and personnel requirements, including capital, expense budget planning and staffing in preparation for commercial production
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