B. Braun

  • QC Principal Microbiologist

    Job Locations US-CA-Irvine
    Requisition ID
    2018-12366
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8:00am- 5:00pm
    Site
    Irvine, CA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc. (CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    The Principal Microbiologist, Quality Control will provide technical expertise and guidance for all activities associated with Microbiology and Sterilization to support Manufacturing, Environmental Monitoring, and Pharmaceutical Research & Development projects. Position will serve as microbiology and sterilization subject matter expert for projects and engage collaboratively with cross-functional areas including production, R&D, sterilization, facilities, engineering, internal laboratories and external contract research and testing facilities. The incumbent shall contribute both strategically and tactically to ensure deliverables are met on-time and within budget. 

     

    Responsibilities: Essential Duties

    • Provide microbiological and sterilization expertise to quality, manufacturing, technical services, engineering and R&D throughout all phases of project including routine manufacturing, innovation, development and technology transfer.
    • Provide microbiological and sterilization expertise to quality, manufacturing, technical services and engineering for continuous improvement initiatives.
    • Provide microbiological and sterilization expertise to quality to sustain and enhance (as needed) the site contamination control strategy.
    • Author and review/approve assessments, procedures, technical reports and other sources of information to ensure that microbiology sampling and testing methods are consistent with compendial guidance, current industry practices and regulatory requirements.
    • Coordinate method development, validation and testing with internal and external microbiology laboratories for a wide variety of testing pertaining to current processes and budgeted R&D projects.
    • Author and review test protocols/data/reports for validating new products /processes to ensure conformance with established specifications and related standard operating procedures.
    • Anticipate /evaluate technical problems and provide recommendations for corrective actions.
    • Write, collect, organize and compile data and reports for use by upper management and to comply with regulatory requirements.
    • Interface with pertinent disciplines to evaluate applicability of existing methods related to Microbiology and Sterilization.
    • Review and/or develop specifications for raw materials, components and finished products.
    • Evaluate, specify and justify Microbiology and Sterilization requirements for major capital projects.
    • Represent company on microbiology and sterilization topics during interactions with regulatory agencies, including interface with FDA inspectors.
    • Participate on cross-functional teams to resolve issues.
    • Manage microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions).
    • Other duties as assigned.

    Expertise: Knowledge & Skills

    • A strong scientific knowledge in areas pertaining sterilization approaches and processes (i.e. moist heat, VHP, radiation, aseptic fill, isolators, RABS).
    • Knowledge of environmental, utility and facility monitoring programs, including area classifications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation.
    • Strong problem solving and troubleshooting capabilities. Good written and verbal business communication skills.  Must be able to work productively in a cross-disciplinary environment.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc.

     

    Required:

    • Degree in Microbiology, Molecular Biology, Biochemistry, or a related science with significant microbiology coursework.
    • Pharmaceutical industry experience at least 8-12 years in a cGMP environment.
    • Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin levels, sub-visible liquid particulate matter analysis, biological indicators (manufacturing, testing & use), and cleanroom contamination control including but not limited to HEPA certification testing requirements, aseptic technique/cleanroom behavior, environmental monitoring, gowning, cleaning/disinfection, sampling methods and sampling plans.
    • Demonstrated industry experience in several of the following areas: microbiological method development and validation, D & z value determination, cycle time reduction (CTR) studies, container-closure integrity testing (CCI), microbial ingress and dye penetration studies, process hold time studies, aseptic process simulations, WFI generation system validation and routine monitoring requirements, equipment cleaning validation, vaporized hydrogen peroxide and UV surface decontamination validation.
    • Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications in alignment with Compendial requirements (for US, and preferably also for EU).
    • Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies.
    • Strong technical expertise with quality risk management programs including experience with performing risk assessments related to product quality impact and establishing process controls that are critical to quality.
    • Limited domestic and/or international travel may be required

    Desired:

    • A Ph.D. or Master’s degree is highly preferred.
    • Experience with manufacturing of small and large volume parenterals is preferred.
    • Experience with Advanced Production Technology e.g. Restricted-Air Barrier Systems, Blow-Fill-Seal, Form-Fill-Seal and Isolator Technology.

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, 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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

    Other

    Responsibilities: Other Duties:

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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