Sr. Microbiologist - Wayne, NJ
Company: Getinge Group
Posted on: August 17, 2019
Together we can make a difference
At Getinge we are dedicated and passionate about helping our
customers save lives and ensure excellent care. We provide
innovations for operating rooms, intensive-care units,
sterilization departments and for life science companies and
institutions. Our portfolio combines well-known product brands such
as Maquet, Pulsion, Atrium, Lancer and Datascope just to name a
A career at Getinge will provide career opportunities that both
inspire and challenge. Here, you can make a difference every
Position Overview: This position could be based in Wayne, NJ or
This position is responsible for the Biocompatibility and sterility
of product manufactured and distributed. It will establish programs
to ensure appropriate environmental controls are in place for
manufacturing and distribution of products. Ensure that all
components, manufacturing materials and products are adequately
assessed and satisfy biocompatibility and sterility requirements as
Primary Responsibilities incudes:
* Maintain periodic sterilization validation requirements for EO
per ISO 11135 and 11137.
* Develops and maintains programs for environmental controls (Air,
Water, Bioburden, etc.) and responsible for periodic
* Maintain and improve validated standards of performance for
* Provide resource to manufacturing and product development teams
to address biocompatibility of materials and ability to
* Identify, develop, and approve corrective actions for out of
* Provide support to departments related to environmental
* Develop and maintain sterilization validation programs, quarterly
dose audits and other applicable requirements.
* Responsible for audits of contract sterilizers and associated
* Resolve out of compliance issues.
* Identify and implement cost savings/ process improvement
* Administer LAL test methods in accordance with AAMI ST72 and
bioburden test programs.
* This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
* A Bachelor of Science in Biology, Microbiology, Chemistry or
related field or equivalent is required. A Master of Science is
* Prior educational background inclusive of courses in toxicology
is highly desirable.
* A minimum of three to five years or more experience managing
microbiological studies in a FDA regulated industry or ISO
certified organization is required.
* Five years of experience evaluating pyrogens, water control
and/or biomaterials is required.
* Prior experience managing environmental monitoring and control
programs is required.
* Must have demonstrated experience analyzing and interpreting
technical results and summarizing these results in technical
* Must demonstrate a working knowledge of current industry
* Must demonstrate effective organizational skills and ability to
manage multiple projects.
* Must have strong knowledge of ETO and Gamma Radiation
GETINGE GROUP IS AN EQUAL OPPORTUNITY EMPLOYER AND ALL QUALIFIED
APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD
TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY,
PREGNANCY, GENETIC INFORMATION, NATIONAL ORIGIN, DISABILITY,
PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY
We look forward to receiving your application. If you share our
passion and believe that saving lives is the greatest job in the
world, then we look forward to receiving your application. We hope
you will join us on our journey to become the world s most desired
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Keywords: Getinge Group, New York , Sr. Microbiologist - Wayne, NJ, Other , Wayne, New York
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