Microbiology Sterilization I
About The Position
Support EO sterilization and microbiological testing activities within a regulated manufacturing environment. Perform microbiological analyses on raw materials, in-process materials, release samples, and stability samples. Prepare, clean, disinfect, sterilize, store, and handle laboratory instruments, materials, products, and supplies. Support sterilization validations including protocol execution, documentation, and report preparation. Interpret and evaluate analytical results against established specifications and support corrective action activities when necessary. Assist in developing, validating, and implementing controlled environment methods and laboratory procedures. Perform qualitative and quantitative testing using standard laboratory equipment and automated instrumentation. Support methodology transfer activities from R&D into manufacturing or laboratory operations. Maintain accurate technical documentation, validation records, protocols, and reports in compliance with GDP requirements. Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support sterilization and microbiological initiatives. Participate in continuous improvement activities related to sterilization, laboratory operations, and microbiological processes. Follow FDA regulations, ISO standards, and company quality procedures. Other duties may be assigned.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemistry, Biomedical Sciences, or related scientific discipline.
- Entry-level candidates are acceptable.
- Equivalent foreign degrees must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
- Knowledge of EO sterilization processes.
- Familiarity with FDA regulations, ISO 11135, ISO 11737, and related sterilization and microbiological standards.
- Strong technical documentation and report-writing skills.
- Ability to support sterilization validations, protocols, and testing activities.
- Strong analytical and problem-solving skills.
- Ability to communicate findings clearly and collaborate effectively with cross-functional teams including Manufacturing, Quality, Regulatory, and R&D.
- Fully bilingual (English and Spanish).
Nice To Haves
- Experience in regulated manufacturing, pharmaceutical, biotechnology, or medical device industries.
- Experience with TrackWise or similar quality management systems.
- Knowledge of environmental monitoring and controlled environments.
- Exposure to validation and laboratory quality systems.
Responsibilities
- Perform microbiological analyses on raw materials, in-process materials, release samples, and stability samples.
- Prepare, clean, disinfect, sterilize, store, and handle laboratory instruments, materials, products, and supplies.
- Support sterilization validations including protocol execution, documentation, and report preparation.
- Interpret and evaluate analytical results against established specifications and support corrective action activities when necessary.
- Assist in developing, validating, and implementing controlled environment methods and laboratory procedures.
- Perform qualitative and quantitative testing using standard laboratory equipment and automated instrumentation.
- Support methodology transfer activities from R&D into manufacturing or laboratory operations.
- Maintain accurate technical documentation, validation records, protocols, and reports in compliance with GDP requirements.
- Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support sterilization and microbiological initiatives.
- Participate in continuous improvement activities related to sterilization, laboratory operations, and microbiological processes.
- Follow FDA regulations, ISO standards, and company quality procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
