• Senior Microbiologist Jobs in United States Of America

  • Abbott India Ltd
  • United States Of America, Usa

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines Our 103,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION Position Summary

This position is for the microbiologist that consistently applies microbiological concepts to the manufacturing and sterilization processes of a medical device and understands and develops process monitoring/metrics to ensure microbiological quality of the final device

Facility and Routine Production Microbiological Support
Develop and execute controlled access environment qualifications, specifications, and environmental disturbance reports
Provide guidance on controlled access environment requirements, including gowning
Develop and execute qualifications of ancillary systems such as process water and compressed air
Provide guidance on cleaning processes and chemical usage
Technical support for facility issues in the areas of environmental monitoring and microbiological methods
Assess manufacturing process changes for microbial impact
Sterilization and microbiological laboratory methods support
Develop sterilization process parameters based on device / packaging design
Troubleshoot sterilization cycle nonconformances
Perform annual sterilization requalification for ethylene oxide, liquid chemical, and steam sterilization processes per regulatory requirements
Perform product sterilization adoptions
Knowledge and ability to perform mathematical sterilization calculations (ie lethality, D-value, etc)
Perform sterilization assessments for changes to process, packaging, load configuration, design, etc Knowledge of reusable device regulatory requirements
Train other microbiologists to test methods and equipment
Proactively identify and share microbiology and sterilization opportunities, concerns, and solutions with cross functional partners
Mentor microbiology technicians/microbiologists and provide technical expertise
Participate in calibration out of tolerance investigations
Documentation and technical writing
Maintains understanding of applicable standards and applies them to qualifications and test methods

Microbiological test methods

Sterilization validations / product adoptions

Equipment qualifications

Microbiological test methods

Writes the following technical documentation

Procedures for routine product monitoring and incoming component specifications

Supplier change notifications

FMEAs

Supplier audits and internal/external audits

Nonconforming material reports

Corrective action preventive action (CAPA) documents

Other Requirements

Other Projects as Directed by Department Manager

Member of R&D project teams, Operations project teams, or supports 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 US 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

Qualifications

Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology

With BS Degree

Minimum of 7 years in a medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience

With Masters Degree

Minimum of 3 years in a medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience

Person in this position demonstrates professional skills with excellent written communication

Articulates technical concepts well

Person in this position has demonstrated troubleshooting skills in complex situations outside of routine out of specification issues, such as sterilization or contamination issues while at the Microbiologist II level or equivalent

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 engage others to accomplish projects

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Strong organizational and follow-up skills, as well as attention to detail

Ability to travel approximately 5-25 PERCENT , including internationally

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
Abbott India Ltdarfix

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