Sterility Assurance Scientist.US-MAN.006

Integra LifeSciences
Mansfield, MA
Closing date
Oct 24, 2021

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Integra LifeSciencesis 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, weve evolved into one of the worlds leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But thats just the beginning.Integra is growing at an unprecedented rate. Were at a moment in time where the experience youll gain is more robust than the experience you bring. And were out to invest in your future because its 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 Integras ongoing commitment to our values and our shared success.Integras 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 employees short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Implements and maintains procedures and methodologies to cover product and cleanroom environmental monitoring and sterilization programs.Gains and applies knowledge of FDA, ISO and EN sterilization and related microbiology standards and guidelines to all tasks.Supports technical assessments of contract sterilizers and laboratories (MUST have GAMMA, EO, Bioburden, Pyrogen, Doese Audit knowledge)Ensures adequacy of contamination control measures at external suppliers.Provides input on the resolution of sterility related non-conformances.Supports sterilization validations, cleaning validations, and supporting activities for all product families and cleanroom.Works with product development and operations to ensure timely and complete sterilization adoptions and validations of all new products.Trains personnel in contamination control and sterilization requirements and procedures.Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.Manages sterile release, bioburden and dose audit, and environmental monitoring programs.Creates and finalizes validation protocols and reports ensuring they are clear, concise and compliant to work instructions and standards.Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance always.Participates in audits and other compliance program-related activities.Executes other duties/responsibilities as assigned by manager.

Bachelors Degree is required, preferably in Microbiology, Biological Sciences or Engineering1 - 3 years of experience in sterilization/microbiology required; preferably in the medical device, pharmaceutical and or / food industry.GAMMA, EO, Bioburden, Dose Audit, Pyrgen Knoelwdge requiredIn 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.

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