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 Microbiologist II, Quality Assurance will provide technical expertise and practical execution of all activities associated with Microbiology and Sterilization to support manufacture of terminally sterilized pharmaceutical products. Position will serve as microbiology and sterilization subject matter expert for Quality Assurance activities, manufacturing operations and projects. Position will engage collaboratively and cross-functionally with other departments to provide microbiological support for activities associated with quality assurance, production, sterilization, facilities maintenance and engineering, method and process validation, product and process development. The incumbent shall contribute strategically, tactically and practically to ensure cGMP compliance of products and processes. Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Provide microbiological and sterilization expertise to establish, maintain and continually improve quality control and assurance programs for manufacture of terminally sterilized pharmaceutical products. Relevant programs and activities may include, but are not limited to:
- Environmental monitoring
- Sterility assurance, including sterilizer cycle development and validation, load monitoring, product testing and parametric release.
- Bioburden monitoring
- Cleaning and disinfection, including validation of cleaning and disinfection processes.
- Establishing hold times for terminally sterilized solutions.
- Development and validation of microbiological analytical methods.
- Particulate matter control
- Container-closure integrity
- Quality investigations
- Author and review procedures, protocols, reports, investigations and relevant sources of information to ensure that microbiology sampling, test methods and quality assurance programs are consistent with current industry practices and regulatory requirements.
- Coordinate and perform method development, validation and testing with support from internal and external microbiology laboratories for process quality, product release and project testing.
- Author and review test protocols/data/reports for validating new products and 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 establish, maintain and continually improve test methods and quality assurance programs.
- Review and/or develop specifications for raw materials, components and finished products.
- Evaluate, specify and justify Microbiology and Sterilization requirements for process improvement, major capital and other 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.
- Coordinate microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions).
Qualifications Expertise: Qualifications - Experience/Training/Education/Etc
- A strong scientific knowledge in areas pertaining sterilization approaches and processes (moist heat, sterility assurance, bioburden control, load monitoring).
- 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 and cooperatively in a cross-disciplinary environment.
- Degree in Microbiology, Molecular Biology, Biochemistry or a related science with significant microbiology coursework.
- Pharmaceutical industry experience, 5-8 years in a cGMP environment.
- Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin, cleaning & disinfection, method validation, particulate matter, and biological indicators (manufacturing, testing & use).
- 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 (including microbial ingress, dye penetration or other methods).
- Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications and programs in alignment with Compendial requirements and current standard practices.
- Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies.
- Graduate degree in relevant field
- Experience with manufacturing and quality assurance of terminally sterilized, large volume parenteral products.
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:
- Limited domestic and/or international travel may be required
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.
One of the world's leading healthcare suppliers.