Validation Engineer

This position is responsible to provide technical leadership in the delivery of the sterilization efforts for Medical products. This includes, supporting the team in conducting studies and performing testing. In addition, position will be responsible to support the communication and publishing of results - This position will collaborate cross functionally with Operations/Production/Engineering to optimize our cleanroom, contamination controls, routine sterilization processes, etc.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Partner with cross-functional leadership to devise and execute sterilization validations within a varying range of modalities such as steam, EO, vapor H2O2 or radiation for regulatory review.

Contribute on sterilization focused projects

Ensure all testing is conducted by approved standards and guidance such as AAMI, AOAC 966.04, ASTM, FDA, EPA, and ISO 14937.

Support laboratory testing and studies including: propagation of bacterial cultures, d-value analysis, spore suspension testing, biological indicator analysis, etc. as defined by management

Analyze and summarize data for cross functional review

Author detailed experimental protocols and reports, standard operating procedures and other controlled documents

Develop and validate laboratory test methods for sustaining products

Provide technical summaries and reviews to leadership regarding sterilization projects, new developments in industry, scientific principles, healthcare guidelines

Applies GMP/GLP in all areas of responsibility, as appropriate

Oversee product evaluation studies, review data, ensure accurate incorporation of results.

BS in Life Sciences from four-year college or university

Five (5) years' experience in microbiology laboratory, medical device industry or analytical testing.

Certified in sterilization for medical devices (AAMI, NAMSA & Nelson provide this course) or trained on a validation by a certified sterilization microbiologist

Demonstrated knowledge of biological indicators (BIs) is required.

Strong knowledge of bacterial endotoxin testing, bioburden testing, environmental monitoring, aseptic technique, Bacteriostasis/Fungistasis testing and biocompatibility is desired.

Emphasis on Ethylene Oxide sterilization

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.