Senior Microbiology Technician

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Microbiology Technician serves as an advanced technical resource within the Quality Control Microbiology team. This role performs complex microbiological testing, supports investigations and validations, and provides day-to-day guidance to junior technicians. The position acts as a bridge between routine laboratory execution and leadership functions by ensuring data integrity, supporting process improvements, and assisting with compliance activities. ESSENTIAL DUTIES AND RESPONSIBILITIES: Technical Execution & Testing Perform advanced microbiological testing including: Bioburden, Endotoxin, Growth Promotion TOC, Conductivity, and Utility testing (e.g., Water, Compressed Air) Conduct Environmental Monitoring of cleanrooms (viable and non-viable samples) Perform product testing of Raw Materials, In-Process samples, and Finished Goods Ensure proper aseptic technique and adherence to GMP/GLP standards and regulations Data Analysis & Trending Review and analyze microbiological data for accuracy and completeness Support trending of environmental monitoring and test results Identify potential adverse trends and escalate appropriately Generate reports and assist in presenting findings to management Investigations & Quality Support Lead or support: Out-of-Specification (OOS) investigations Non-conformances and CAPAs Perform root cause analysis and recommend corrective/preventive actions Collaborate cross-functionally (QA, Manufacturing, Engineering) to resolve quality issues Validation & Continuous Improvement Support microbiological method validations and qualifications (e.g., EMPQ, utilities) Assist with implementation of new methods, systems, and process improvements Contribute to SOP development, revisions, and continuous improvement initiatives Training & Mentorship Train and mentor junior staff on: Testing methods Aseptic technique SOPs and compliance requirements Provide day-to-day technical guidance and troubleshooting support in the lab Compliance & Audit Readiness Ensure compliance with FDA, ISO 13485, and other regulatory standards Assist in preparation for and participation in: FDA inspections Internal and external audits Maintain accurate and timely documentation in accordance with GMP requirements Laboratory Operations Monitor laboratory equipment and ensure proper calibration and maintenance Maintain inventory of materials, reagents, and supplies Ensure laboratory cleanliness and adherence to safety standards Coordinate sample management, including send-outs to external laboratories Additional Responsibilities Assist in special projects and departmental initiatives Support KPI tracking and reporting Perform other duties as assigned DESIRED MINIMUM QUALIFICATIONS: Education & Experience Bachelor’s degree in Microbiology, Biology, or a related scientific field 4–7 years of experience in a cGMP-regulated environment (medical device, pharmaceutical, or related industry) Technical Skills Strong knowledge of microbiological testing methods and aseptic techniques Experience with environmental monitoring and cleanroom operations (ISO Class 7/8 preferred) Familiarity with FDA regulations and ISO quality standards Experience with method validation and investigation processes Competency Strong analytical and problem-solving skills Ability to recognize deviations and recommend effective corrective actions Excellent organizational and time management abilities Effective written and verbal communication skills Ability to work independently and collaboratively across teams Proficiency with Microsoft Office and laboratory data systems Behavioral & Professional Expectations Effective communication: Clearly conveys technical information verbally and in writing; escalates issues appropriately and collaborates cross-functionally Prioritization & time management: Effectively manages multiple tasks, organizes workload, and consistently meets deadlines in a fast-paced QC environment Adaptability: Demonstrates flexibility and maintains performance when priorities shift or urgent issues arise (e.g., EM excursions, investigations) Attention to detail: Ensures high accuracy in documentation, data review, and execution of test methods Problem-solving mindset: Proactively identifies issues, proposes solutions, and supports continuous improvement initiatives Accountability & ownership: Takes responsibility for assigned work, follows through on commitments, and ensures compliance with GMP standards Team collaboration: Works effectively within the lab and with cross-functional teams; supports a positive, quality-focused culture Mentorship & support: Provides guidance to junior staff, reinforces best practices, and supports training and knowledge sharing Salary Pay Range: $29.86 - $40.91 USD Hourly Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and