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Job Field: Legal Jobs
Location: Irvine, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Company: B.BraunRequisition #: 3185Job Title: QA Validation Engineer Sr. SpecialistState: CaliforniaCity: IrvineJob Description: We are currently seeking a QA Validation Engineer Senior Specialist who will provide Validation and Quality Engineering Support to new and existing Pharmaceutical Manufacturing Operations.1. Interface with Management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met.2. Design and execute Validation Plans and Programs for new and improved pharmaceutical manufacturing processes and products.3. Design and implement Quality Control and Quality Assurance systems for new and existing pharmaceutical manufacturing processes and products.4. Provide leadership and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.5. Prepare and present technical investigative reports to Management as directed.6. Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues.7. Assist in the supervision of associate validation staff including specialized contract personnel/vendors in the performance of validation services.8. Represent B. Braun in contacts with regulatory agencies, including interface with FDA investigators.To qualify for this position candidates must possess a BS degree in an engineering or scientific discipline with minimum of ten years of experience in a pharmaceutical QA/QC Validation or Engineering position; a Certified Quality Engineer is preferred; at least 5 years project management experience; demonstrated knowledge and expertise within the areas of Industrial Quality Control, Quality Assurance, and Validation for manufacturing equipment and processes; demonstrated knowledge in Industrial Statistics and its application to Pharmaceutical Manufacturing and Quality Control; expertise in US FDA cGMPs and QSR as well as comparable international regulatory agency requirements for product design, development, manufacturing and quality assurance/control; knowledge in software applications supporting statistical data analysis, word processing, project management; familiarity and understanding of manufacturing methods related to Quality Control, and other disciplines such as engineering, chemistry, microbiology and sterilization assurance; knowledge of lean manufacturing techniques (eliminating waste, improving efficiencies and uptime, and improving productivity).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 affirmative action - equal opportunity employer.Through its Sharing Expertise

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