Sr. Microbiologist

What You'll Do

• Apply advanced knowledge of microbiological concepts, practices, and procedures related to FDA, EU, ISO 17664, ISO 17665, ISO 10993, AAMI ST79, AAMI TIR 30, AAMI TIR 12, and applicable BS EN ISO standards
• Ensure and maximize biocompatibility of products, components, materials, and consumables using industry guidelines and advanced testing technologies
• Perform microbiology, sterilization, biocompatibility, and chemical assessments for new product introductions, design/process changes, and day-to-day activities
• Actively support and advise on existing processes and new product development
• Manage laboratory testing related to reprocessing, manufacturing (cleaning and sterilization), and biocompatibility according to procedures and standards
• Oversee cleanroom environmental control (air, surface, particle viability) and facilities (e.g., water systems) in accordance with applicable standards
• Interpret sampling and monitoring data using statistical and analytical techniques to determine control and trends
• Continuously identify opportunities for trend stabilization and statistical process control to drive cost savings
• Own, drive, and support NC/CAPA activities, including non-conformance correction and root cause analysis
• Manage relationships with cleaning service providers, sterilization and testing laboratories, and collaborate with the Supplier Quality team
• Complete gap assessments of external documents related to biocompatibility, reprocessing, and manufacturing activities
• Work cross-functionally with Manufacturing Engineering, R&D, Operations, and Regulatory Affairs to develop best practices
• Participate in change control board activities and internal/external regulatory audits (FDA, BSI, GMED, etc.)
• Execute quality initiatives that support compliance and continuous improvement of Biological Safety processes
• Perform validations/(re)qualifications and develop/improve SOPs and work instructions aligned with evolving standards
• Act as a subject matter expert in microbiology-related regulations and local procedures
• Coach, mentor, and train team members and functional groups in Biological Safety
• Serve as backup for Biological Safety activities across sites as needed

What You Bring

• Bachelor's degree in Microbiology or a related discipline (Biomedical Engineering, Biology, etc.)
• Minimum of 3 years of experience in a quality or regulatory affairs related environment
• Minimum of 2 years of experience as a Microbiologist focused on Cleaning, Biocompatibility, and Sterilization, plus 2 years related to microbiology and chemistry
• 2+ years of applied device or pharmaceutical microbiological or biological testing, R&D, or sterility assurance experience
• Understanding of sterilization techniques such as gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, dry heat, or other modalities
• Mandatory experience interacting with regulatory agencies (FDA, Department of Health, TUV, BSI, etc.)
• Excellent knowledge of U.S. and international medical device regulations and standards in Biological Safety
• Highly proficient in statistical techniques, data review, and analysis
• Strong communication, negotiation, project management, and influencing skills
• Critical thinking, innovative reasoning, and excellent problem-solving abilities
• Ability to work independently, manage multiple priorities, and mentor others

Compensation

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $80,000.00 - $90,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, technical expertise, and market conditions.

Benefits include

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company