Senior QC Microbiologist

Position Overview

The Senior, QC Microbiology supports QC, detecting, and mitigating microbial contamination across facilities, utilities, processes, and products. The roleapplies 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.

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-Whys, 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.
• 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.

Minimum Requirements:

• Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 8+ years’ experience OR
• Master’s degreein chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 6+ years’ experience OR
• PhDwith 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).

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.