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VACANCY REFERENCE NUMBER 156345
Senior Scientist - Microbiology - Alabama
Location: United States : Birmingham, AL
Function: Innovation Management (R&D)
Career Level: Senior professionals (> 5 years)
Legal Entity: Evonik Corporation
Business Line: Health Care
What we offer
You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.
Click here to learn more about Evonik from our employees
This Senior Scientist in the Microbiology Laboratory functions as a project leader and Subject Matter Expert (SME). This position is primary responsibilities are managing new projects, conducting microbial investigations, drafting, and updating Standard Operating Procedures (SOP), drafting method and equipment qualification protocols, reviewing Good Documentation Practices (GMP) documentation, and guiding/training junior members of the microbiology laboratory. This position will also perform routine microbiological testing, method development testing, and other laboratory support functions as needed.
* Has a sound understanding of the skills required to train, development, and perform routine testing on the following activities:
* Microbiological Assays and Testing - a) Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins; b) Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates; c) Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy; d) Biological Indicators Performance Test, e) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods.
* Environmental Monitoring - Monitoring of Classified Areas using a) active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi; and b) Air sampling methods for the detection of Total Particulates; trending of this data to detect anomalies, and characterize the transient and resident microflora.
* Utilities -Testing of a) clean steam and Water for Injection (WFI) for total microbial count and presence of endotoxins; and b) nitrogen and process air for total microbial count and total particulates.
* Leads and performs microbial investigations.
* Conducts qualification of standard microbiological tests and equipment.
* Develops, drafts and updates SOPs and other GMP documentation.
* Understands aseptic processing and terminal sterilization principles and guidelines.
* Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS).
* Represents the Microbiology Laboratory during site audits and client/internal meetings.
* GMP Documentation - Document test results and conclusions in a GMP manner. Ensure test forms are complete before submission for approval.
* Performs responsibilities in compliance with Evonik quality systems.
* Adheres to all company safety, health and environmental policies, procedures and directives.
* Conducts all laboratory activities in a safe manner by use of safety data sheets (SDS) to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel.
* Bachelor's degree in microbiology, biological sciences, or related field of study.
* Minimum 6 years experience in a clinical, academic, or industrial/pharmaceutical microbiology laboratories or Master's degree with 3 years of related experience.
* Experience in microbiological assays and testing.
* Experience in environmental monitoring and trending.
* Experience in the testing of utilities.
* Experience with equipment qualification, and SOP/method development.
* Excellent written and verbal communication skills.
* Excellent organizational and leadership skills.
* Proficiency in current Good Laboratory Practices (cGLP) and current Good Manufacturing Practices (cGMP).
* Excellent computer skills including experience with Microsoft Excel, Microsoft Word, Microsoft Project and Microsoft Visio.
* Ability to use a respirator.
* Ability to work with microorganisms and hot liquids.
To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.
VACANCY REFERENCE NUMBER 156345
Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.
Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.