Senior Microbiology Technician

Overview

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.

• Perform advanced microbiological testing including:
  Bioburden, Endotoxin, Growth Promotion TOC, Conductivity, and Utility testing (e.g., Water, Compressed Air).
• Conduct Environmental Monitoring of clean rooms (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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Assist in special projects and departmental initiatives.
• Support KPI tracking and reporting.
• Perform other duties as assigned.

• 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).

• 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.

• 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.

• 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…