Medical Device – Microbiologist
TÜV SÜD
工作地点
New Brighton, MN, USA
雇佣形态
全职工
招聘信息详细内容
Established more than 150 years ago in Germany, TÜV SÜD is a leading global provider of technical services with more than 25.000 highly skilled employees across 1,000 offices worldwide. For over 30 years, throughout 33 locations, it is TÜV SÜD America’s priority to create a safer future. To protect people, property and the environment from technology-related risks; we drive consumer protection digital transformation, sustainable development, and urbanization.
Tasks/Aufgaben
Overview:
The Microbiologist will provide support to the Biological Safety, Reusable Device, and Lot Release (BRL) team, establishing TÜV SÜD’s new 20,000 square foot medical device testing laboratory. This position is responsible for performing laboratory-based microbiology studies in a fast-paced environment according to ISO 10993, ISO 11737-1, ISO 11737-2, GLP/GMP, and other applicable guidelines established for the medical device industry. The ideal candidate has a strong laboratory background in the medical device and microbiology testing industries.
Qualifications/Qualifikationen
Responsibilities:
Assist in the development of laboratory quality system, compliance, laboratory support, and test method documentation
Execute equipment installation, qualification, validations, routine maintenance, and monitoring
Provide support in laboratory method development
Execute testing including sterilization validations (EO, Steam, Dry Heat, Gamma), cleaning and disinfection validations, endotoxin testing, bioburden testing, sterility testing, water testing, method suitability, and residual hemoglobin, protein, and carbohydrate analysis
Provide scientific support to the Microbiology Team Lead and other scientific staff in the study design, conduct, and interpretation of test assays to ensure technical integrity of studies
Assures adherence to protocol, protocol amendments, company SOPs and industry standards throughout the conduct of studies
Utilize strong time management skills to efficiently perform and analyze multiple studies while adhering to study timelines
Assures that all data including unanticipated responses are accurately recorded, verified, and organized
Collaborate and clearly communicate with cross-functional teams to ensure clients’ needs are met
Report clear and concise updates and results to laboratory management
Assist with training of scientific laboratory analysts
Contribute to continual lab improvements including new method development and improvement of methods
Ability to work and be effective with minimal supervision while prioritizing and executing daily project tasks
Maintain ancillary records (logbooks, worksheets) according to protocols, SOPs, and GLP regulations
Performs necessary cleaning and maintenance of equipment and lab spaces
Prepares and maintains necessary glassware and equipment via washing, autoclaving, and dehydrogenation as needed
This laboratory role will be full time, Monday through Friday, with possible but infrequent weekend work
Other duties as assigned by management
Qualifications:
Minimum BS/BA in microbiology or related field
Minimum 3 years of applicable experience in a laboratory environment
At least two years of experience in Reusable Medical Device Reprocessing
Sterilization (EO, Steam, Dry Heat, Gamma), bioburden, sterility, and endotoxin testing experience
Strong working knowledge of industry regulations (ISO 10993 series of standards, ISO 17025, ISO 13485, ISO 10993, ISO 11135, ISO 11737-1, ISO 11737-2, GMP and GLPs) supporting the medical device environment
Knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
Ability to organize and track multiple projects in a detail-oriented and self-directed manner
Strong Organization And Problem-solving Skills Required
Strong technical writing and oral communication skills
Exhibit excellent communication skills and be a proactive, collaborative team player
Self-starter with a positive and motivated attitude
Further Information
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee is regularly exposed to sharps, bacterial and fungal lab strains, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses are required in the laboratory.
The employee is regularly required to stand, walk, use hands, talk, and hear. The employee is occasionally required to crouch, bend, twist, and reach. The employee is occasionally required to lift and/or move up to 50 pounds and lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity, and visual-kinesthetic coordination.
Equal Opportunity Employer — Disability and Veteran
TUV SOD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.
For more information on applicable equal employment regulations, please refer to the following: Labor Law Posters
