Senior QC Microbiologist

Mission

The Senior, QC Microbiology supports t 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Job Description

• Monitoring and trending - trend monitoring 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.
• Process support – 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.
• Investigations and CAPA – leads or supports investigations for deviations, OOS/OOT, EM excursions, and contamination events; perform root cause analysis (e.g., fishbone, 5-Why, FMEA); define and implement effective CAPAs and effectiveness checks.
• Data, Metrics, and Reporting – 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.
• Method Development/Validation – 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.
• Training and Coaching – develops and delivers training for operators and site staff on aseptic technique, gowning, EM practices, and contamination control behaviors; perform qualification and requalification assessments
• Cross-Functional Collaboration – partners with Manufacturing and MSAT/Engineering on facility design and improvements; support GEMBAs and change management.
• Audit/Inspection Readiness – 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.

Minimum Requirements

• Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 8 + years’ experience OR Master’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 6 + years’ experience OR PhD with 4 + years of applicable industry experience; 8 years of relevant microbiology experience in cGMP pharma/biotech or sterile medical device manufacturing, including environmental/utility monitoring, aseptic processing, and contamination control.
• Hands-on experience with compendial methods (USP/EP/JP), endotoxin testing (LAL), bioburden, sterility testing, EM, and microbial identification.
• Experience supporting or executing validation for sterilization, aseptic processing (media fills), and cleaning/sanitization.

Preferred Requirements

• Experience with rapid microbiological methods (e.g., PCR/qPCR, ATP), LIMS and eQMS systems, and statistical tools (e.g., Minitab/JMP).