Job description
STRATEGIC FOCUS: (The focus desired and expected on the position over the next 1-3 years)
- Perform responsibilities in compliance with Evonik quality systems and provide support to all manufacturing and validation activities.
- Adhere to all company environmental, health and safety policies and procedures.
- Conduct all laboratory and cleanroom activities in a safe manner and according to appropriate written procedures.
- Perform microbiological assays according to USP, EU, ISO regulations and Evonik procedures and test methods.
NATURE & SCOPE:
Qualifications – If you were transferred to a new position, list the specific education, skills, training, and relevant experience (in a similar or lower level position) that your replacement would need to qualify for this position.
- Bachelor’s degree in microbiology, biological sciences, or related field of study
- Minimum 2 yr. experience in a clinical, academic, or industrial/pharmaceutical microbiology laboratories.
- Experience in microbiological assays and testing.
- Desired experience in environmental monitoring and trending.
- Desired experience in the testing of utilities.
- Excellent written and verbal communication skills.
- Excellent organizational and leadership skills.
- Proficiency in Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMP).
- Excellent computer skills including experience with spreadsheets and databases.
- Ability to use a respirator.
- Ability to work with microorganisms and hot liquids.
- Has a sound understanding of the skills required to perform the following routine 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 for total microbial count and presence of endotoxins; and b) nitrogen and process air for total microbial count and total particulates.
- Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS).
- 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 MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel
Your Application
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
Company is
Evonik Corporation
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