Microbiology Coordinator I

About the role

The Microbiology Coordinator I will lead cleanroom and sterilization validation, microbiological analysis, and environmental control activities at Viant Medical's Heredia site. Reporting to the Quality Director, the role ensures compliance with FDA, ISO, and GMP standards while supporting other Viant facilities.

Key responsibilities

• Prepare, review, and approve quality documents and microbiology department procedures.
• Initiate and investigate non‑conformances, complaints, calibrations, and environmental monitoring results.
• Maintain and verify compliance of all microbiology testing equipment.
• Participate in internal, external, and customer audits and readiness activities.
• Execute and review validation protocols (IQ, OQ, PQ, TMV) for equipment and processes.
• Perform microbiology testing such as LAL, bioburden, and environmental monitoring.
• Generate quality metrics for management and operations reviews.
• Supervise and train Microbiology Technicians, assigning tasks and ensuring proper procedures.

Required profile

• B.S. in Biotechnology, Biology, Microbiology, Chemistry or equivalent technical degree.
• 0‑3 years experience in medical device or pharmaceutical cleanroom monitoring.
• Basic to intermediate English proficiency (A2‑B2).
• Knowledge of FDA Quality System Regulation, ISO 13485, GMP, and related standards.
• Ability to work independently in an onsite laboratory environment.

Required skills

• Understanding of FDA QSR, Medical Device Directive, ISO 13485, GMP, USP regulations.
• Basic statistical techniques and descriptive statistics.
• Proficiency with Minitab statistical software.
• Root cause analysis tools and methodologies.
• Experience with equipment validation (IQ, OQ, PQ, TMV).