CAPS Microbiologist II

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:

Responsible for leading the CAPS QC Microbiology team to support CAPS pharmacies with microbiological testing and special projects.

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.
• Direct responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory 00S 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 proactively develops the education standard of the responsible persons.

Expertise: Knowledge & Skills

• 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. Mayperiodically assist in orienting, training, and/or reviewing 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 withexternal contractors/vendors.
• cGMP experience/training required, Aseptic processing training/experience required

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Bachelors degree required, Master's degree preferred.
• Proven and/or demonstrated skills/abilities in leadership, educational training and/or experience will be taken into consideration.
• Previous supervisory experience.
• cGMP experience/training required, Aseptic processing training/experience required

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
• Frequently: Stand, Sit, Visual Acuity with or without corrective lenses
• Constantly: N/A

Activities:

• Occasionally: Finger feeling, Reaching upward and downward, Talking - ordinary, loud/quick
• Frequently: Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Walking
• Constantly: N/A

Environmental Conditions:

• Occasionally: Gases
• Frequently: Exposure to toxic or caustic chemicals (in most areas) , Fumes
• Constantly:N/A

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.

• Noise Intensity:Moderate
• Occasionally: Other
• Frequently: Lab environment
• Constantly: N/A

Salary Range:$67,261 - $84,076

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.