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:
Provide validation and quality engineering support to new and existing pharmaceutical manufacturing operations. Responsibilities: Essential Duties
Expertise: Knowledge & Skills
- Provide quality engineering support toward the design, development, installation, start-up, validation and maintenance of products, process, equipment, facilities and critical utilities.
- Provide technical expertise and specialized knowledge in validation and quality control systems for pharmaceutical clean rooms and critical utilities.
Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required:
- Demonstrated knowledge of basic engineering principals related to facilities and utilities validation.
- Must have organizational and planning skills.
- Must be able to handle projects with minimum supervision.
- Must be able to read and understand drawings and schematics.
- Must have a basic understanding of Installation, Operational and Performance Qualification requirements for General Clean Room Facility and Critical Utilities.
- Must have a good understanding of Documentation procedures and GMPs for the healthcare industry.
- Must have an excellent understanding of Quality Control Release Verification (QCRV) and work order system.
- Must have an excellent understanding of Chemistry and Microbiology testing requirements.
- Must interface effectively with management personnel, engineering, manufacturing and other technical disciplines.
- Coordinate with manufacturing and support laboratories to support QCRV releases.
- Schedule contract personnel and outside vendors in the performance of contracted services.
- Prepare qualification test protocols and write test reports.
- Update supervisor and project team on the status of the projects.
- Coordinate project activities with other department or outside vendors.
- Prepare and present technical investigation reports to Validation Engineering.
- Formulate recommendations for disposition or other actions related to field performance issues.
- Assist in the design and implementation of Validation Plans and Programs for new and existing pharmaceutical manufacturing processes and products.
- High school graduate plus 2 years experience in technical field and college degree.
- Prior experience highly desirable.
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.
One of the world's leading healthcare suppliers.