Senior Microbiology Technician

Integra LifeSciences•Braintree, MA

9d•$30 - $41•Onsite

About The Position

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.

Requirements

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
Clearly conveys technical information verbally and in writing; escalates issues appropriately and collaborates cross-functionally
Effectively manages multiple tasks, organizes workload, and consistently meets deadlines in a fast-paced QC environment
Demonstrates flexibility and maintains performance when priorities shift or urgent issues arise (e.g., EM excursions, investigations)
Ensures high accuracy in documentation, data review, and execution of test methods
Proactively identifies issues, proposes solutions, and supports continuous improvement initiatives
Takes responsibility for assigned work, follows through on commitments, and ensures compliance with GMP standards
Works effectively within the lab and with cross-functional teams; supports a positive, quality-focused culture
Provides guidance to junior staff, reinforces best practices, and supports training and knowledge sharing

Nice To Haves

ISO Class 7/8 preferred

Responsibilities

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
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