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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:

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

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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