Microbiologist Ii

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Accountabilities & Responsibilities:

• Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• May assist with training to other staff members performing duties in the microbiology area.
• Maintain sterilization systems for Integer products. With guidance, conduct sterile validations and adoptions for new products.
• Performs testing to ensure product safety and meet biocompatibility requirements of FDA, ISO, Japanese Ministry of Health, and other regulatory agencies.
• Coordinates the cleanliness and contamination control programs for Integer manufacturing areas. May assist in the development of the control programs as needed.
• May assist in the selecting and auditing of a contract sterilizer and testing laboratories.
• Generate protocols, final reports, and validations related to biocompatibility and environmental monitoring.
• Supports product development, production, and product transfer teams on biocompatibility, as well as environmental impacts of new product introductions and production line layout changes.
• Performs other duties as required.

Education & Experience:

• Minimum Education: Minimum Education: Bachelor's degree in one or more of the following disciplines: Biology (Biological Sciences), Microbiology, Molecular Cell Biology (MCB), Biochemistry or Chemistry. Alternatively, two years of experience in a related field may be substituted for every year of education.
• Minimum Experience: Three (3) to five (5) years of experience in the medical device manufacturing industry and at least (2) years' experience in microbiology.

Knowledge & Skills:
Special Skills:

• Ability to apply skills in microbiology and develop new methods to solve complex problems.
• Skilled in multi-tasking and prioritizing.
• Excellent written and verbal communication skills. Good presentation skills.

Specialized Knowledge:

• General knowledge of GLP, GMP and QSR.
• Working Knowledge of Medical Device Regulatory requirements including FDA, ISO and PMDA Ministry of Health (Japan).
• Knowledge of scientific theories and methods pertaining to bioburden, LAL, and water testing.
• Ability to interpret relation of bacterial identifications.
• Experience with the methods of biocompatibility testing and the ability to interpret the data in relationship to current industry guidance.
• Knowledge of EO sterilization process and requirements to maintain a sterile cycle.

Other: Physical demands include equal amounts of sitting, standing, and walking (including stairs and between buildings). High level of computer keyboard typing and computer screen viewing. Lift boxes up to 40 lbs. Use problem-solving techniques, high degree of attention to detail, work effectively on teams and communicate effectively with and lead people inside and outside the department
U.S. Applicants: EOE/AA Disability/Veteran