Senior Microbiologist - Environmental Monitoring

Glaukos•San Clemente, CA

74d

About The Position

The Microbiologist- Pharma and Medical Devices - position will be based in San Clemente, CA and will directly support the manufacture of innovative ocular medical devices and pharmaceuticals. This role includes ensuring proper execution of Environmental Monitoring (EM) tasks, reviewing routine and event-based environmental related project protocols, validations, reports, and data assessments. The candidate will perform microbiological testing including bioburden testing, LAL, growth promotion and other laboratory analysis. The candidate will coordinate and monitor EM-related activities to ensure quality and timely completion of tasks. The candidate is also expected to work collaboratively with internal cross-functional groups- R&D, Operations, Facilities - and with external contract vendors. The role involves evaluating environmental monitoring results and support manufacturing operations.

Requirements

Environmental Monitoring experience required.
Gowning experience for ISO 7/ISO 8 cleanrooms
Manufacturing or production experience required.
Growth Promotion experience
Solid Understanding of cGMPs and regulatory requirements.
Understanding and working experience in classified environments including ISO 14644.
Experience working in a regulated industry, FDA preferred.
Good written and verbal communication skills and ability to collaborate and interact with a team.
Strong computer skills, particularly MS office (Word, Excel, PowerPoint).
Adaptable to changing priorities in a fast-paced environment, positive attitude.
Position is First Shift, but Second Shift and weekends may be required.
Must be able to stand / walk for extended periods of time.
Minimal travel required between Glaukos campuses - San Clemente & Aliso Viejo.
Excellent time management skills with the proven ability to meet deadlines and prioritize tasks
Bachelors Degree in Microbiology, Biology, Biochemistry
5-8 years of experience in microbiology
GDP Experience

Responsibilities

Support sampling activities within ISO-classified cleanroom environments.
Oversee external contractors performing EM sampling.
Enter, review, and trend EM data.
Perform routine microbiological laboratory analysis, such as environmental Monitoring, and LAL testing on bulk and finished products for device and combo products. Method development for LAL testing of new products.
Maintains laboratory policy and procedures; assist in developing and writing protocols and procedures. Prepare and update of the GMP/ISO procedures relevant to microbiology and environmental monitoring activities.
Review and approve Facilities Data Logs and BMS system entries for cleanrooms.
Report writing (investigations, protocols, writing final reports).
Perform Microbiology testing Bioburden and Growth Promotion.
Train, coach, and mentor junior staff on microbiological and EM procedures.
Train and support laboratory personnel, coordinate with contract labs, and support cross-functional teams if needed.
Perform technical microbiology skills, such as aseptic technique, streak plating, gram staining, microscope use.
Issue Purchase Orders for laboratory supplies and equipment.
Investigate excursions, out of -specification results, and trends, implementing corrective/preventative action as needed.
Submit samples for Dose Audit: Reviewing results for bioburden, sterility and microbial Identification. Generating quarterly Dose audit reports and other technical documentation
Other duties as assigned by management.