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B Braun Medical
Chemical Process Quality Engineering Specialist
Location: Irvine,
California-Orange County
92614
Posted on:
9/24/2009 12:13:00 PM
Postion type:
Full time
Job Code:
1183
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
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.
REQUIREMENTS:
* BS/BA degree in Chemical Engineering, with 5 years experience in pharmaceutical/chemical industry.
or:
* MS/MA degree in chemistry or scientific discipline, with 3 years experience in pharmaceutical/chemical industry.
or:
* PhD degree in chemistry or scientific discipline, with 1-2 year experience in pharmaceutical/chemical industry.
and:
Knowledge:
* Basic understanding and experience with formulating injectables (especially LVPs).
* Basic understanding and experience with analytical chemistry such as: wet chemistry, HPLC, GC, FT-IR, UV-VIS, Polarimetry, AA.
* Basic understanding and experience with analytical chemistry technique such as: pipetting, weighing, quantitative transferring.
* Understanding of cGMP, USP, ICH guidelines, AOAC, and EP.
* Basic writing skills and experience with writing protocols, reports, proposals.
* Basic troubleshooting and minor repairs of analytical instrument such as HPLC, GC.
B.Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com An EOE
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
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