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Microbiology Sterilization I
Job Location:
Job Location:
Salinas, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
17 May 2026 (30+ days ago)
Posted:
Application Deadline:
25 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Main Responsibilities:
- 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
- Minimum 3 year of relevant experience in the regulated industry.
- Bachelors degree in Science (Microbiology Biology Biotechnology Biomedical Sciences).
- Entry-level candidates are acceptable.
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
Work Methodology:
- 100% on site job
- Full time job
- 1 year of first contract term with expectation of continuity based on performance and budget
- Location: Salinas PR
- Administrative shift
- Type of industry: Medical devices
