Easter Seals Jobs

Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

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.

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)