Microbiologist II
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Job Location:
Minnetonka, MN - USA
Monthly Salary:
$ 61300 - 122700
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
MAIN PURPOSE OF THE ROLE:
This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device.
MAIN RESPONSIBILITIES:
Facility and routine production microbiological support: Provide Facility Microbiological support including EM BSC testing DI systems and compressed air testing; Record review of routine microbiological test results; Technical support for facility issues in the areas of environmental monitoring and microbiological methods; Conduct routine out of specification investigations; Develop and execute controlled access environment deionized water compressed and air qualifications; Assess manufacturing process changes for microbial impact; Complete environmental disturbance reports; and Complete annual controlled access environment reports.
Technical sterilization and microbiological laboratory methods support: Routine release of manufactured product; Data analysis of sterilization processes; Writes protocols and reports for qualifications for sterilization and microbiological test methods; Conduct new product assessments for sterilization adoption or validation; Assist in the development of sterilization cycles; Develop laboratory test methods and train technicians as appropriate; Works with technicians in conducting these qualifications; Complete LAL sampling analysis; and Develop microbiological specifications for incoming components
Documentation: Ensures correct documentation linkage flow for microbiologically related documents.
Writes new or updates current microbiologically related documents.
Maintains understanding ofapplicable standards and applies them to qualifications and test methods.
Writes protocols and reports for qualifications for sterilization and microbiological test methods: Writesappropriate validation protocols; performs or oversees validations for new technologies equipmentand/or test methods; and creates documentation for implementation.
Technical Training: Provides training to laboratory technicians on new equipment or new test procedures and provides training in the areas of sterilization validation and sterilization processes.
Other Projects as Directed by Department Manager.
Support all Company initiatives as identified by management and in support of Quality Management.
Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements
Company policies operating procedures processes and task assignments. Maintains positive and
Cooperative communications and collaboration with all levels of employees customers contractors and vendors.
The role is performed in an office setting and will not be performed in a laboratory setting.
Education
Bachelors Degree ( 16 years)in Microbiology or related science (OR) an equivalent combination of education and work experience
Masters Degree ( 18 years)Preferred.
Experience/Background
- Minimum 2 years with a Masters degree 2 years medical device/pharmaceutical or related industry with experience in microbiology and/or sterilization and relevant microbiology laboratory experience.
- Minimum 5 years With a Bachelors degree 5 years in a medical device/pharmaceutical or related industry with work experience in microbiology and/or sterilization and relevant microbiology laboratory experience.
- Demonstrates professional skills with excellent written communication.
- Able to work with minimal supervision and ability to maintain regular and predictable attendance.
- Demonstrated excellent troubleshooting skills in routine out of specification situations at the Microbiologist I level.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills as well as attention to detail.
- Ability to travel approximately 5-10% including internationally
The base pay for this position is
$61300.00 $122700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) Work in a clean room environmentAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
IC
Key Skills
- Laboratory Experience
- Aseptic Technique
- Virology
- Clinical Laboratory Experience
- FDA Regulations
- Laboratory Procedures
- PCR
- Microbiology
- Quality Control
- GLP
- cGMP
- Laboratory Information Management Systems
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
