Senior Microbiology Technician

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 and internal/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