Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:Benefit plans that meet all local statutory requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program
SUMMARY DESCRIPTIONQualified 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 monitoringWater system monitoring Bacterial endotoxin test method validation and monitoringBioburden test method validation and monitoringResponsibilities 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 RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential dutySatisfactorily: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.Mentors non-senior level microbiology staff. 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.
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.