Senior QC Microbiologist

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Senior, QC Microbiology supports the QC, detecting, and mitigating microbial contamination across facilities, utilities, processes, and products. The role applies microbiology principles to validate sterilization, aseptic processing, and cleaning/sanitization; executes environmental and utility monitoring; and ensures compliance with FDA, EU, and global regulatory requirements. This position leads complex testing and data analysis, investigates contamination events and deviations, and partners cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS) to maintain product quality and patient safety. This role exists to ensure microbiological control, robust validation, and data-driven decision-making throughout the product lifecycle.

Requirements

Microbiology principles
Validate sterilization, aseptic processing, and cleaning/sanitization
Execute environmental and utility monitoring
Compliance with FDA, EU, and global regulatory requirements
Complex testing and data analysis
Investigate contamination events and deviations
Partner cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS)
Compendial and rapid methods
Authoring trending reports and organisms’ evaluation
Author/execute protocols and reports for sterilization (SIP/terminal), aseptic process simulations (media fills), cleaning and sanitization validation, and disinfectant efficacy studies
Align with Annex 1 and applicable standards
Lead or support investigations for deviations, OOS/OOT, EM excursions, and contamination events
Perform root cause analysis (e.g., fishbone, 5-Whys, FMEA)
Define and implement effective CAPAs and effectiveness checks
Perform statistical analysis and trending
Maintain LIMS/QMS records
Generate dashboards (EM performance, utilities, sterility assurance KPIs)
Present to site governance for data-driven decisions
Implement and validate compendial and rapid microbiological methods (e.g., bioburden, endotoxin/LAL, sterility, microbial ID via MALDI-TOF/16S, qPCR, ATP bioluminescence)
Perform change controls and tech transfers
Develop and deliver training for operators and site staff on aseptic technique, gowning, EM practices, and contamination control behaviors
Perform qualification and requalification assessments
Partner with Manufacturing and MSAT/Engineering on facility design and improvements
Support GEMBAs and change management
Support internal audits and regulatory inspections
Remediate findings
Maintain inspection-ready documentation and areas
Perform and Exercise independent judgment to respond to EM excursions, water alerts, and in-process contamination signals
Escalate per SOP and CCS
Interpret regulations and standards to recommend controls and CAPAs
Select appropriate test methods and sampling strategies within approved procedures

Nice To Haves

Experience with Fujifilm's Genki culture

Responsibilities

Monitoring and trending of cleanrooms (air, surfaces, personnel), utilities (WFI/PW, clean steam, compressed gases), and materials for microbial contamination using compendial and rapid methods; ensure timely data review and alert/action response. This includes authoring trending reports and organisms’ evaluation.
Authors/executes protocols and reports for sterilization (SIP/terminal), aseptic process simulations (media fills), cleaning and sanitization validation, and disinfectant efficacy studies; align with Annex 1 and applicable standards.
Leads or supports investigations for deviations, OOS/OOT, EM excursions, and contamination events; perform root cause analysis (e.g., fishbone, 5-Whys, FMEA); define and implement effective CAPAs and effectiveness checks.
Performs statistical analysis and trending; maintain LIMS/QMS records; generate dashboards (EM performance, utilities, sterility assurance KPIs), and present to site governance for data-driven decisions.
Implements and validates compendial and rapid microbiological methods (e.g., bioburden, endotoxin/LAL, sterility, microbial ID via MALDI-TOF/16S, qPCR, ATP bioluminescence); perform change controls and tech transfers.
Develops and delivers training for operators and site staff on aseptic technique, gowning, EM practices, and contamination control behaviors; perform qualification and requalification assessments.
Partners with Manufacturing and MSAT/Engineering on facility design and improvements; support GEMBAs and change management.
Supports internal audits and regulatory inspections; remediate findings; maintain inspection-ready documentation and areas.
Performs and Exercises independent judgment to respond to EM excursions, water alerts, and in-process contamination signals; escalates per SOP and CCS.
Interprets regulations and standards to recommend controls and CAPAs; selects appropriate test methods and sampling strategies within approved procedures.
Decisions typically involve moderate to complex issues with significant quality impact; consults with QA and site leadership for batch-impacting decisions.
Perform other duties as assigned.