Sterility Assurance Scientist- Microbiologist
Company: Integra LifeSciences
Posted on: July 23, 2021
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
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.
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
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
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.
of geographic location, our commitment is to offer the following,
plans that meet all local statutory requirements
range of programs that reflect typical local market
opportunity for employees to tailor benefits to their specific
that balance employee’s short-term and long-term needs
HERE for more
information regarding our benefits and total rewards
and maintains procedures and methodologies to cover product and
cleanroom environmental monitoring and sterilization
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
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.
duties/responsibilities as assigned by manager.
Degree is required, preferably in Microbiology, Biological Sciences
1 - 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 required
Keywords: Integra LifeSciences, Boston , Sterility Assurance Scientist- Microbiologist, Other , Mansfield, Massachusetts
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