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Wilmington, DE 19806
Element has an opportunity for Microbiologist. The Microbiologist is responsible for development, validation, verification of sterility cycles, and testing to determine sterility, microbial limits, endotoxin, and preservative effectiveness and other microbiological assays. This role is also involved in technology transfers, stability testing, applications of parenteral technologies and environmental monitoring. All work is performed under FDA cGMP regulations.
+ Develop, validate and perform microbiological and sterility tests on a wide variety of products
+ Participate in aseptic production of small batch parenteral, ophthalmic and transdermal products
+ Draft test methods and report results in accordance with company policies
+ Maintain a clean and safe work environment
Skills / Qualifications
+ BS/MS in Microbiology or Medical Technology
+ 2 to 5 years hands-on experience in performing microbiology in a cGMP environment
+ Comprehensive understanding of the USP chapters related to pharmaceutical microbiology
+ Knowledge of clean room operations
+ Experience in working the pharma CRO industry
+ Excellent organizational skills and the ability to manage multiple projects
+ Experience in cGMP documentation and data recording.
+ Proficiency in Microsoft Applications (Word, Excel)
+ Availability, flexibility, and maturity to represent the company at a broad range of events/projects in the community, with customers and within the company.
+ Ability to remain calm when faced with mounting pressure related to deadlines and multiple priorities.
+ Well developed oral and written communication skills to meet a variety of communication needs. Good interpersonal skills that foster open upward and downward communication built on mutual respect.
We are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.
We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.
Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.
Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.
We have four values that we strive to live by every single day.
+ Safety – We keep our colleagues and visitors safe
+ Integrity – We act honestly and fairly to do the right thing
+ Excellence – We set new standards of excellence in everything we do
+ Partnership – We work together for the benefit of our customers
When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY. We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.
Job Locations US-DE-Wilmington