Summary:

Microbiologist I will perform environmental, compressed gasses, purified water testing and reporting, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance in the Microbiology lab.  

 

Essential Duties and Responsibilities:

Perform environmental particulate and microbial testing for ISO certified cleanrooms, Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air Gas Systems, and Pharmaceutical Grade Water Systems Perform laboratory testing including, but not limited to, bacterial gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing Perform all tasks related to laboratory upkeeping and the environmental monitoring program Coordinates testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations, creating and maintaining Purchase Orders) Responsible in managing the lab inventory for laboratory testing Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program Coordinates and supports facility, equipment, and HVAC maintenance events between multiple departments Coordinates and supports risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs Creates Experimental Requests to support special studies and projects Coordinates and supports Performance Qualification and Validation protocols and reports Coordinates and supports test method validations in support of microbiology operations Coordinates and supports equipment, product, and process cleaning and disinfection validations Maintains regulatory compliance of the sterilization program for sterile implantable devices by coordinating and supporting process re-qualifications, new product qualifications, and risk assessments Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives Reviews and approves environmental monitoring data and laboratory equipment and records Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness Works and communicates effectively and professionally with others inside and outside the company Maintains regulatory compliance of the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air and Gas Systems, and Pharmaceutical Grade Water Systems Execute and complete daily tasks per schedule under the guidelines of established Standard Operating Procedures (SOP sand cGMP regulations)

 

Required Qualifications:

Microbiology, Biology, or equivalent Bachelor’s degree Able to communicate effectively and computer literate

 

Preferred Qualifications: (Optional)

2+ years relevant hands-on microbiological testing experience. Fresh Graduate encourage to apply Experience in setting-up and maintaining laboratory equipment and instrument for lab testing Possess knowledge in Quality Management System will be an added advantage Experience in Medical Industry will be an added advantage