Senior Microbiologist EO Sterilization

  • Anywhere

Company :
Integer Holdings Corporation

Location :
Chaska, Minnesota

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

Apply Job :
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Description :
At Integer, our vision and values are embedded in everything we do! If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now! Accountabilities_&_Responsibilities * Adheres to Integer s Values and all safety, environmental, security a 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. * Provide direction and training to other staff members performing duties in the microbiology area. * Develop, validate and maintain sterilization systems for Integer products. Conduct sterile validations and adoptions for new products. Coordinate and train staff to assure that all functions involved in completing the production sterile runs are carried out. * Develop and perform testing to ensure product safety and meet biocompatibility requirements of FDA, ISO, Japanese Ministry of Health and other regulatory agencies. * Develop and coordinate the cleanliness and contamination control programs for Integer manufacturing areas. Coordinate environmental monitoring on all cleanrooms. Provide training and guidance on regulations for cleanroom operations. Provide guidance on water quality management. * Select and audit contract sterilizer and testing laboratories. * Primary customer and regulatory body contact on sterilization, cleanliness policies and biocompatibility issues. * Complete protocols, final reports, and validations related to sterilization, biocompatibility and environmental monitoring. * Provide guidance and leadership to product development, production and product transfer teams on biocompatibility and sterilization requirements, as well as environmental impacts of new product introductions and production line layout changes. * Apply continuous improvement/lean concepts to identify and eliminate non- valued added tasks and/or activities. * Apply problem solving methodologies 8D, PDCA, DMAIC to identify root cause and create and implement corrective and preventive actions. * Performs other duties as required. Special_Skills Knowledge & Skills: * Ability to apply advanced skills in microbiology and develop new methods to solve complex problems. * Ability to exercise independent judgement in developing methods, techniques and evaluation criteria * 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. * Knowledge of 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 validate and 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. Education_&_Experience 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 * Five (5) to eight (8) years experience in the medical device manufacturing industry and at least (3) years experience in microbiology. Show moreShow less