Microbiology Technician I
About The Position
Selution, in partnership with Cordis, develops and commercializes advanced drug-device combination products for coronary and peripheral artery disease. The Microbiology Technician I supports routine microbiology laboratory and environmental monitoring activities at the Irvine manufacturing site. The role includes bacterial endotoxin testing, environmental sampling, laboratory documentation, equipment and supply management, and other laboratory activities performed in accordance with applicable procedures, ISO 13485, cGMP, GDP, and laboratory safety requirements. The technician works with cross-functional teams to support cleanroom monitoring and related projects, and helps maintain the microbiology laboratory in a compliant, organized, and inspection-ready state. The role is scheduled for the day shift, approximately 8:00 a.m. to 4:30 p.m., with some weekend work of approximately 4–6 hours, one to two times per month. The expected pre-tax pay rate is $21.95–$27.50 per hour. Actual pay may vary based on skills, education, experience, job-related knowledge, and location. US work authorization is required; candidates requiring sponsorship for a work-authorized visa will not be considered.
Requirements
- High school diploma or equivalent.
- Proficient computer skills, including Microsoft Word and Excel.
- Knowledge of aseptic technique.
- Knowledge of micropipette techniques.
- Working knowledge of cGMP and GDP requirements.
- Strong organizational skills.
- Strong written and verbal communication skills.
- Critical-thinking skills sufficient to support laboratory investigations.
- Ability to work efficiently in a fast-paced environment while maintaining accuracy and attention to detail.
- Availability to work the day shift, approximately 8:00 a.m. to 4:30 p.m., with some weekend work of approximately 4–6 hours, one to two times per month.
- US work authorization; sponsorship for a work-authorized visa is not available.
Nice To Haves
- At least 1 year of experience in the medical device industry or a similar regulated environment.
- Experience with cleanroom environmental monitoring.
- Microbial culturing experience.
- Experience using a Laboratory Information Management System (LIMS).
Responsibilities
- Perform lot-release bacterial endotoxin testing (BET) and testing associated with applicable protocols.
- Perform environmental sampling within a Class 8 cleanroom.
- Apply aseptic and micropipette techniques during laboratory activities.
- Support cleanroom monitoring activities and other microbiology-related projects.
- Assist with equipment qualifications and test method qualifications.
- Follow applicable microbiology and site-wide procedures under ISO 13485, laboratory safety requirements, cGMP, and Good Documentation Practices.
- Maintain accurate and complete laboratory documentation in support of quality and regulatory requirements.
- Review and enter environmental monitoring data.
- Maintain laboratory equipment records and related documentation.
- Perform administrative activities, including scanning and filing.
- Keep laboratory records organized, accurate, and appropriately maintained.
- Perform routine laboratory sustaining activities, including opening and closing the laboratory.
- Handle biohazard waste in accordance with applicable procedures.
- Maintain media, laboratory instruments, and supplies required for routine operations.
- Monitor laboratory supply inventory, generate purchase orders, coordinate ordering, and receive materials and supplies.
- Collaborate with cross-functional teams on cleanroom environmental monitoring and related projects.
- Communicate with internal stakeholders about laboratory activities, testing, documentation, and operational needs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
