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Under direct supervision of Director, Quality Reliability Microbiology, this individual will have a dotted line reporting structure to animal and human tissue site quality leaders. Responsibilities associated with this Sr. Microbiologist, Animal Tissue, include working with Integra manufacturing sites and suppliers in support of compliance requirements for human and animal tissue products. Qualified candidates must possess relevant experience as a Microbiologist in Animal and Biological Tissue Medical Device Technology, including knowledge of ISO 22442 requirements and its application in medical devices.

The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance of animal and human tissue medical products. This position reports into Global Laboratories, Microbiology, and Sterility Assurance department and working with the Princeton, NJ Integra corporate site. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Subject Matter Expert (SME) auditor of animal and human tissue suppliers

Generation and/or quality SME reviewer of protocols and reports to qualify changes to animal and human tissue product designs, manufacturing processes, and supplier processes

Assess the risk of relevant zoonotic diseases and human pathogens to Integra’s animal and human tissue products

Provide SME input to design and process risk assessments for tissue products

Provide SME input to manufacturing process validations intended to reduce tissue-based contamination risks (i.e. viral inactivation, mitigation of cross contamination, etc.)

Interpret microbiological data to identify trends and issues that require investigation

Create, own, and maintain global procedures that substantiate compliance to ISO 22442

Support responses to regulatory authorities related to human and animal tissue products

Perform audits as SME for animal and human tissue suppliers

Ensure compliance of global procedures to ISO 22442-2, EU 722/2012 and associated annexes, and Rule 17 for animal tissue medical devices.

Contribute to risk management activities including PFMEA generation.

Mentors non-senior level microbiology staff as needed.

Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary.

Change control, non-conformance and CAPA support as human and animal tissue SME.

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

DESIRED MINIMUM QUALIFICATIONS

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

Minimum required education and experience:

Bachelor’s degree or equivalent with 6+ years of experience, Master's degree with 3+ years of experience, Doctoral degree with 2+ years of experience. Relevant experience would include working with animal and/or human tissue products. Bachelor’s, or preferably Master of Science degree, in Microbiology, Virology, Animal Science, or Veterinary Science.

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.

Preferred experience conducting microbial test method and viral inactivation validations and managing projects independently.

Working knowledge of ISO 22442-2, 722/2012 and associated annexes, and Rule 17 for animal tissue medical devices is required.

Ability to track milestones and manage projects.

Working knowledge of applicable regulations and their interpretation within industry.

Ability to travel 5-10%.

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.

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