Senior Microbiologist: Biocompatibility & Sterilization Lead

VB Spine; Leesburg (VA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Health insurance and benefits

401(k) with company match

Paid time off

Job summary

VB Spine is seeking a Senior Microbiologist to lead Biological Safety activities across the Spine division. You will oversee microbiology, biocompatibility, sterilization, and cleaning, ensuring safety and regulatory compliance for medical devices throughout their lifecycle.

The role requires 3+ years in quality/regulatory environments and 2+ years focused on cleaning, biocompatibility, and sterilization, plus strong regulatory interaction experience with FDA and other agencies.

Qualifications

• Bachelor's degree in Microbiology or related discipline is required.
• Minimum 3 years in quality or regulatory affairs environments.
• 2+ years as a microbiologist focusing on Cleaning, Biocompatibility and Sterilization, plus microbiology/chemistry.
• 2+ years in device/pharma microbiology, testing, R&D, or sterility assurance.
• Experience with sterilization techniques (gamma, EO, H2O2, moist/dry heat).
• Experience interacting with FDA, Health Dept, TUV, BSI, etc.

Responsibilities

• Apply microbiology concepts to FDA, EU, ISO standards and industry guidelines.
• Ensure biocompatibility of products and materials using testing and guidelines.
• Perform microbiology, sterilization, biocompatibility, and chemical assessments for new products and changes.
• Manage lab testing related to reprocessing, manufacturing, and biocompatibility.
• Oversee cleanroom environment and facilities in compliance with standards.
• Interpret data to determine control and trends using statistical methods.
• Support NC/CAPA activities and root cause analysis.
• Collaborate with QA, Regulatory, Manufacturing, and R&D across sites.

Skills

Strong communication

Project management

Statistical analysis

Problem solving

Mentoring

Quality/regulatory experience

Microbiology testing

Biocompatibility

Sterilization

Regulatory agency experience

Medical device regulations

Data review

Influencing skills

Critical thinking

Independent work

Education

Bachelor's degree in Microbiology or related discipline

Job description

VB Spine is seeking a Senior Microbiologist to lead Biological Safety activities across the Spine division. You will oversee microbiology, biocompatibility, sterilization, and cleaning, ensuring safety and regulatory compliance for medical devices throughout their lifecycle.

The role requires 3+ years in quality/regulatory environments and 2+ years focused on cleaning, biocompatibility, and sterilization, plus strong regulatory interaction experience with FDA and other agencies.