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Senior Microbiologist

Employer
Integra Life Sciences
Location
Boston, Massachusetts, US
Salary
Competitive
Closing date
May 16, 2022

View more

Sector
Academic / Research
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Career Home › Job Search Results ›Senior Microbiologist

Changing lives. Building careers.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

RESPONSIBILITIES

Responsibilities

SUMMARY DESCRIPTION

Qualified candidates must possess relevant experience as a Microbiologist in one or more of the following areas and be considered a Subject Matter Expert in a minimum of one area:

Controlled environment monitoring

Water system monitoring

Bacterial endotoxin test method validation and monitoring

Bioburden test method validation and monitoring

Responsibilities associated with this position are directly associated to microbiological testing and monitoring used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological control programs for the purposes of interpreting data, implementing procedures, and remediation projects. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed above. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. This position reports into Corporate Quality Microbiology but will be located in Boston. Remote candidates with the ability to travel to Boston as needed will also be considered.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty

Satisfactorily:

Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.

Design experimental plans to address specific laboratory issues as needed.

Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.

Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11135, CMDR, Medical Device Directive, and USP.

Interpret microbiological data in order to identify trends and issues that require investigation.

Contribute to risk management activities including PFMEA generation.

Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments.

Create procedures for microbiological testing and sampling in alignment with validations and in compliance with application regulations.

Serve as Microbiology representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract resources.

Experience with Controlled environment monitoring, Water system monitoring, compressed air monitoring, Bacterial endotoxin test method validation and monitoring and Bioburden test method validation and monitoring preferred.

Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

Ensure compliance in area(s) of subject matter expertise across company manufacturing sites.

Create governing procedures in area(s) of subject matter expertise and facilitate implementation across company manufacturing sites.

Support and address comments and suggestions associated with microbiological test method validations and monitoring procedures.

Change control, non-conformance and CAPA support.

Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

QUALIFICATIONS

What are we looking for?

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Bachelor's, or preferably Master of Science degree, in Microbiology or similar discipline.

4-7 years of experience in a Microbiology focused role for a medical device or pharmaceutical environment.

Demonstrates excellent organizational and communication skills.

Results oriented with a strong focus on quality principles.

Excellent technical writing skills with an understanding of good documentation practice.

Experience conducting microbial test method validations and managing projects independently.

Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.

Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 11135, and USP.

Ability to track milestones and manage projects.

Working knowledge of applicable regulations and their interpretation within industry.

If remote, ability to travel as needed to Boston, MA

In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas - big and small - are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

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 (https://www.eeoc.gov/laws/index.cfm) |EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm) 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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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