OverviewAbout B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.ResponsibilitiesPosition Summary:Responsibilities: Essential Duties
- Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.
- Directly responsible for the supervision of testing operations for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS results.
- Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.
- Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.
- Participates in projects, task force jointly with internal customer departments in case the needs arise.
- Prepares trend analysis and data compilation on deviation in the production process when required.
- Participates in internal and external audit.
- Participates in the Global Microbiology Task Team, whenever required.
- Responsible in microbiological release of Pharma products and Pharma incoming materials.
- Supports microbiological tasks for process validation.
- Will serve as microbiology and sterilization subject matter expert for projects and engage collaboratively with cross functional areas
- Trains and proactively develops the education standard of the responsible persons.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.Expertise: Knowledge & Skills
QualificationsExpertise: Qualifications -Education/Experience/Training/EtcRequired:
- Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
- Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
- Bachelor's degree required, Master's degree preferred.
- 10-12 years related experience required.
- Regular and predictable attendance
- Ability to work non-standard schedule as needed
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.
B. 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.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.