Microbiologist
Company: The Judge Group
Location: Leesburg
Posted on: April 19, 2024
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Job Description:
Our client is currently seeking a Microbiologist for an 8 month
+ contract.***Candidates MUST have gamma sterilization
experience***Description/Comment: *** As a Microbiologist you will
apply cGLP, cGMP, ANSI, AAMI, ISO, EUMDR, FDA and USP guidelines to
the bioburden, cytotoxicity, bacterial endotoxin, and
biocompatibility analysis of orthopedic implants and surgical
instruments for Leesburg, VA facility. --- Actively support new
product validation activities. --- Participate in the development
and improvement of the manufacturing processes for existing and new
products. --- May lead in the development, review and approval of
sterilization process and equipment validation/qualifications (IQ,
OQ & PQ). --- Be the point of contact for suppliers for new process
development, quality issues and process improvements for assigned
projects. --- Assist in Tech Doc preparation and updates. ---
Assist with Notified Body responses - research to find the how, why
and what is needed to meet EUMDR requirements --- Assist with
impact assessment reviews prior to launch/implementation. ---
Assess various ISO Standard revisions and the associated impact to
existing process/procedures.Qualifications: --- Bachelor's Degree
in Biology, Microbiology, or a closely related life science. --- 5
years of applied device or pharmaceutical microbiological or
biological testing, research and development, or sterility
assurance experience. --- Must understand the fundamentals of one
of the following sterilization techniques: gamma irradiation,
ethylene oxide. --- Prefer demonstrated competency in advanced
testing technologies. --- Prefer demonstrated knowledge of
statistics. --- Demonstrated knowledge about a variety of
microbiological concepts, practices, and procedures. --- Ability to
use ISO, AAMI, USP, ANSI, EUMDR and related guidelines toward the
design, manufacturing, development, and launch of initiatives. ---
Ability to effectively work cross-functionally with Product
Development, Operations and Marketing. --- Demonstrated ability to
manage workload. --- Demonstrated communication skills across
different organizational levels. --- Must be results oriented, a
quick learner, team player and able to respond to the urgent needs
of the team ensuring all deadlines are met. --- Demonstrated
ability to technically mentor associate engineers and
scientists.Additional Job Details: ** Onsite in Leesburg, VA-Local
candidates only. **Hybrid 1 or 2 days a week after showing
knowledge and understanding of procedures and processes. --- We are
seeking gamma sterilization experience; however, also looking for
knowledge of manufacturing cleaning. --- Deep understanding of ISO
19227 validations is a plus. --- Micro experience specific to new
product rather than circulated product (we do not oversee reusable
cleaning/steam sterilization for example). --- Ability to quickly
process data sets in Excel is also critical in addition to being
able to handle a fast-paced environment.
Keywords: The Judge Group, Baltimore , Microbiologist, Other , Leesburg, Maryland
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