Microbiologist II

MAIN JOB RESPONSIBILITIES / COMPETENCIES
1. Perform routine microbiological testing, including:
a. Environmental Monitoring (Viable and Non-Viable)
b. Water system testing (bioburden/HPC, endotoxin/LAL, TOC, conductivity/resistivity as applicable)
c. Product bioburden and endotoxin testing
d. Growth promotion and media qualification
e. Gram staining and macroscopic/microscopic morphology of organisms
2. Review and analyze microbiological data for accuracy, completeness, and compliance.
3. Perform routine trending of environmental monitoring and water system data and generate reports and present findings to QC and cross-functional teams.
4. Support microbiological investigations related to environmental monitoring, water system results, and product-related microbiological excursions, including root cause analysis and CAPA implementation as applicable.
5. Ensure compliance with GDP and data integrity requirements while maintaining laboratory inspection readiness, supporting equipment qualification/calibration activities .
6. Train and mentor junior staff on microbiological techniques and provide technical support to manufacturing, engineering, and quality teams to ensure proper aseptic and sampling practices.
7. Identify and support continuous improvement initiatives within microbiology laboratory operations, including implementation of new methods, technologies, and cross-functional process improvements.
8. Manage microbiology laboratory operations, including maintaining inventory levels, ordering laboratory supplies and materials, and ensuring uninterrupted support for routine testing and manufacturing activities.
9. Travel to other STAAR facilities, as required.
10. Perform additional duties assigned by Quality Control management.

REQUIREMENTS

EDUCATION & TRAINING
• Minimum of a Bachelor of Science (BS) degree in Microbiology or equivalent combination of education/experience.

EXPERIENCE
• Minimum 4-6 years of experience in microbiology within medical device, pharmaceutical, or biologics industry.
• Working experience with and understanding industry best laboratory practices, techniques, equipment, materials and mathematical calculations, required.
• Hands-on experience with environmental monitoring programs, water systems (Purified / Process Water), and microbiological testing concepts including bioburden and endotoxin (LAL) testing required.
• Experience with FDA QSR, ISO 13485, and GMP requirements required.
• Experience with FDA QSR, ISO 13485, and GMP requirements required.
• Experience with development, writing and execution of equipment qualifications and method validations, preferred.

SKILLS
• Strong knowledge of microbiological techniques and laboratory practices.
• Ability to independently execute and troubleshoot microbiological methods.
• Strong analytical and data trending skills.
• Familiarity with statistical tools (e.g., trending).
• Excellent documentation, communication, and organizational skills
• Ability to work independently and collaboratively in a team environment.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Proficiency in written and spoken English required.

Pay range: $100K - $125K salary - Final compensation will depend on experience.

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law. #USA