Sr. Specialist, Contamination Control
About The Position
The Sr. Specialist, Contamination Control, supports cGMP manufacturing by owning the Contamination control strategy and work with site teams to prevent, detect, and mitigate microbial contamination across facilities, utilities, processes, and products. This role applies microbiology, engineering, sterility assurance principals to validate that sterilization, aseptic processing, cleaning/sanitization frequency/strategy; clean room, environmental and utility monitoring strategy; meets or exceeds compliance with FDA, EU, and global regulatory requirements. The position leads/supports complex data analysis, investigations related to contamination events, 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, Contamination control strategy and data-driven decision making throughout the facility and product lifecycle.
Requirements
- Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR
- Masters in Life Sciences or Engineering and 6+ years of applicable experience OR
- PhD in Life Sciences or Engineering and 4+ years of applicable experience
- Experience with compendial methods (USP/EP/JP), endotoxin testing (LAL), bioburden, sterility testing, EM, and microbial identification.
- Prior experience in customer relationship management.
- Experience supporting or executing validation for sterilization, aseptic processing (media fills), and cleaning/sanitization.
- Familiarity with regulatory frameworks: 21 CFR Parts 210/211 (and 600 series as applicable), EU GMP/Annex 1, ICH Q9/Q10, ISO 14644/14698; knowledge of Contamination control principles.
Nice To Haves
- Experience with statistical tools (e.g., Minitab/JMP).
- ASQ CQA, ASQ CQE, RAC, or equivalent.
Responsibilities
- Authors and 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.
- Trend monitors 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.
- 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.
- Maintains cGMP-compliant records; author/review SOPs, test methods, sampling plans, and CCS (Contamination Control Strategy) content; ensures alignment with 21 CFR 210/211, 600s, EU GMP/Annex 1, USP/EP/JP, ISO 14644.
- 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.
- Support implementation of compendial and rapid microbiological methods (e.g., bioburden, endotoxin/LAL, sterility, microbial ID via MALDI TOF/16S, qPCR, ATP bioluminescence); oversee 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 other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
