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.

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!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

What You’ll Do

• 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 MALDITOF/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

Minimum 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.

Preferred Requirements:

• Experience with statistical tools (e.g., Minitab/JMP).
• ASQ CQA, ASQ CQE, RAC, or equivalent.

Working Conditions & Physical Requirements:

• Will work in environment which may necessitate respiratory protection X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).