Senior Microbiology Technician

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 41,135 - 56,357; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) savings plan

Disability insurance

Job summary

TEI BIOSCIENCES INC is seeking a Microbiologist to perform advanced microbiological testing and lead investigations in their Braintree, MA facility. The role requires a Bachelor’s degree and 4-7 years of experience in a cGMP environment. Responsibilities include compliance with FDA regulations, method validations, and staff training.

Join us to innovate and improve healthcare standards while working in a collaborative and quality-focused team.

Qualifications

• 4–7 years of experience in a cGMP-regulated environment (medical device, pharmaceutical, or related industry).
• Familiarity with FDA regulations and ISO quality standards.
• Experience with method validation and investigation processes.

Responsibilities

• Perform advanced microbiological testing including Bioburden, Endotoxin, Growth Promotion.
• Lead investigations for Out-of-Specification results and recommend corrective actions.
• Support microbiological method validations and contribute to process improvements.
• Ensure compliance with FDA and ISO standards during laboratory operations.

Skills

Microbiological testing methods

Aseptic techniques

Environmental monitoring

Analytical skills

Problem-solving skills

Organizational skills

Communication skills

Microsoft Office proficiency

Education

Bachelor’s degree in Microbiology, Biology, or a related scientific field

Job description

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.

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

• 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.

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 & Benefits

Pay Range: $29.86 - $40.91 USD Hourly.

Benefits include: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

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 as outlined above. Employees are eligible for the following Total Rewards.

Equal Opportunity Employer

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: EEO Is the Law | EOE including Disability/Protected Veterans. 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 [e-mail].