B. Braun

  • Supv II Microbiology

    Job Locations US-CA-Irvine
    Requisition ID
    B. Braun Medical Inc
    # of Openings
    Position Type
    Regular Full-Time
    7am - 4pm
    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.


    Position Summary:


    Plan, organize and manage the activities related to environmental monitoring, batch releases, coordination and scheduling of samples to be tested, and supervise media and sterility testing activities. Manage the development and implementation of related programs to maximize efficiencies of staff and budgetary resources necessary to support the company goals while complying with regulatory requirements. 


    SHIFT: Sunday - Thursday 7:00am - 4:00pm


    Responsibilities: Essential Duties

    • Oversee and supervising all activities of the QC Microbiology Laboratory.
    • Generate environmental monitoring, product testing schedule and coordinate sample receipt from Manufacturing, Process Control and Validations and delivery to the appropriate QC Microbiology laboratories.
    • Responsible microbiological culture media and reagent receipt, quarantine, testing and release to support laboratory operations.
    • Provide technical guidance to staff and ensure the commercial laboratory testing process is well defined, adheres to current Good Manufacturing Practices (cGMP), and meets all company and regulatory requirements.
    • Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
    • Review raw data and enter, verify and/or release results with a Laboratory Information Management Systems (LIMS).
    • Ensure all analyst and equipment are appropriately qualified for analytical testing in cGMP and GxP environments.
    • Conduct and document investigations for OOS results, environmental excursions and other laboratory discrepancies as required.
    • Directs the investigation of microbiology related in-process, finished product and environmental systems excursions.
    • Interact with other QC Microbiology departments to ensure effective and efficient communication of critical information.
    • Interface on an as needed basis with Regulatory Affairs in conjunction with NDA/ANDA submissions.
    • Interface with FDA and other regulatory agencies during Prior Approval (PAI), routine or field complaint inspections
    • Implement process validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
    • Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
    • Provides technical support to R&D, Validations, and Sterilization Engineering for new product development.
    • Writes and/or reviews environmental data trending reports for sterility suite on a routine and timely basis.
    • Writes, revises and approves microbiology department procedures.
    • Responsible for maintaining departmental budget including leading cost savings initiatives.
    • Other duties assigned. 

    Expertise: Knowledge & Skills

    • Broad knowledge of scientific theories, instrumentation and techniques:
    • Experience with Kinetic Quantitative Chromogenic Lysate and/or Kinetic Turbidimetric bacterial endotoxin test preferred
    • Experience with Steritest® sterility test apparatus and methods preferred
    • Experience with both Microscopic and Light Obscuration Particle Count Tests (HIAC or equivalent) preferred.
    • Thorough knowledge of cGMPs and USP requirements and microbiological test methods.
    • Experience with Laboratory Information Management Systems preferred. 


    Expertise: Qualifications - Experience/Training/Education/Etc



    • BA/BS degree in Microbiology or closely related field and 5-7 more years of experience in a pharmaceutical or medical device company with 2 to 4 years previous supervisory or managerial experience.


    • N/A

    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.


    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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