Microbiology Sterilization I

• 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.
  

Requirements

Education

• 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).
  

Required Skills & Qualifications

• 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).
  

Preferred Qualifications

• 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.
  

Technical Skills

• Microsoft Office Suite
  


• TrackWise
  


• Agile environment exposure
  


• Technical documentation
  


• Sterilization validation support
  


• Microbiological testing techniques
  


• Controlled environment practices