Fahrenheit IT Elkton , MD 21921
A leading global Medical Device manufacturer has an excellent opportunity for a Senior Sterility Assurance Specialist serves as a subject matter expert on current medical device terminal sterilization technologies (i.e. EO, Radiation), controlled environments, and related microbiological testing in their Elkton, MD office.
This opportunity is a contract or contract-to-perm opportunity based on W2/1099/Corp-to-Corp. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact us at or and call Rose Chu, VP in Pharmaceutical & Biotech Services Group at # for questions.
We are always interested in talking to candidates for current AND future opportunities! Please respond directly to Global Employment Solutions, Inc. at with your resume attached
Plan and execute sterility activities to support new/modified products and processes in accordance with applicable regulations, standards and guidelines.
Serve as a subject matter expert on current medical device terminal sterilization technologies (i.e. EO, Radiation), controlled environments, and related microbiological testing.
Supports New Product Development and Operations Engineering teams creating and implementing plans for sterility assurance activities to support new/modified products/processes
May lead the development/modification of sterilization processes for new or existing products
Develop, review and approve sterilization process qualifications and routine dose audits.
Develop, qualify and implement microbiological test methods to support sterility assurance of products
Review sterilization and laboratory documentation to ensure compliance with procedures
Apply cGLP, cGMP, AAMI, ISO, FDA USP guidelines to microbiological development validation such as bioburden, bacterial endotoxin, growth promotion
Support cleanroom and installation and qualification activities including protocol development, review and/or approval.
Lead investigations to resolve sterilizer non-conformance reports, including corrective/ preventative, by applying knowledge of industry standards
Bachelor degree in Biology, Microbiology, or related science.
Minimum of 7 years of experience with sterilization process in medical device industry of which 5 years of experience in ethylene oxide sterilization validation
Demonstrated experience in development and modification of sterilization processes
Significant knowledge of EO sterilization requirements of ISO 11135 and gamma sterilization ISO 11137 is required. With knowledge in other sterilization techniques such as dry or moist heat desirable.
Demonstrated experience in a variety of microbiological methods (bioburden, bacterial endotoxin, microbial isolation and characterization)
Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes
Working knowledge of Good Laboratory and Good Manufacturing practices.
Knowledge of product particulate testing a plus.
Keywords: QUALITY engineer, Biocompatibility, Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC, implementing the supplier management process, Supplier Management process, Quality Engineering, DFEMA's (Design Failure Mode Effect Analysis) and PFMEA's, supplier quality engineering, Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC, CQE, CQA, Supplier Quality, requests for impact on quality system and required controls, Facilitating and performing component/material qualifications, supplier management, Trending of supplier metrics
We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc- Sterility Specialist) in the subject line of your correspondence to ensure review.
Please forward your credentials in Word format, in confidence, to: Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Global Employment Solutions/Fahrenheit IT
P C F )
One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004
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Analysis, Biology, Development, FDA, ISO, Laboratory, Manager, Management, Medical Device, Metrics, Protocol, Recruiter, Testing, Validation