Position OverviewThe Senior, QC Microbiology supports t 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 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).
