Senior Microbiology Technician

About the role

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.

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
• Absorb and participate in: FDA inspections, Internal and external audits
• Absorb and maintain accurate and timely documentation in accordance with GMP requirements
• Laboratory Operations
• Maintain laboratory equipment and ensure proper calibration and maintenance
• Maintain inventory of materials, reagents, and supplies
• Ensure laboratory cleanliness and adherence to safety standards
• Carefully 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

Qualifications

• Desired Minimum Qualifications:
• Education & Experience: Bachelor’s degree in Microbiology, Biology, or a related scientific field
• Experience: 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

Skills

• Strong analytical and problem-solving skills
• 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

Benefits

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 group legal insurance, and savings plan (401(k)).

Pay

Pay Range: $29.86 - $40.91 USD Hourly

Schedule

Not specified

Location

Not specified