About 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.Position Summary:
The individual will be part of microbiological method validations for the site. This individual will work specifically in Aseptic Fills and Isolators Independently execute existing lab equipment re-qualification and new equipment qualification for the Duplex Facility. Perform variety of routine and non routine tasks including non-conformance and OOS investigation for laboratory and manufacturing operations, writing investigation reports, protocols and updating procedures and other documents. Support other projects assigned as required by the department. 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 test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS result.
- 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 production personnel 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 medical devices or Pharma products and Pharma incoming materials.
- Supports microbiological tasks for process validation.
- Trains and pro-actively 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
Expertise: Qualifications -Education/Experience/Training/EtcRequired:
- Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
- Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
- Bachelor's degree required.
- 02-04 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.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:
While performing the duties of this job, the employee is expected to:
- Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
- Occasionally:Reaching upward and downward, Push/pull, Stand, Visual Acuity with or without corrective lenses
- Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Stooping/squatting, Walking
- Frequently:Sitting , Standing, Talking - ordinary, loud/quick
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.
- Noise Intensity:Low
- Occasionally:Office environment, Production/manufacturing environment
- Constantly:Lab environment
Equal Opportunity Employer Veterans/Disabled