Full Time

5 - 10 years

4 Year Degree

0-10%

Senior Scientist is responsible for supporting sterilization validations and biological indicator qualifications on a global basis. Requires expertise in sterilization processes and validations and knowledge of AAMI/ISO sterilization standards, along with complex problem-solving and analytical skills.

Job Duties:
Support development of sterilization specifications, validation protocols, and equipment functional requirements. Provide sterilization and biological indicator consulting services to facilities on a worldwide basis.

Implement test procedures and protocols in support of the development of new pharmaceutical, vision care, and surgical products in alignment with the appropriate FDA, ISO, and corporate standards.

Coordinate completion of validation-associated activities, including sterilization, cleaning, and rapid microbiology methods.

Participate on and provide support to PDMP product development teams, as assigned.

Perform testing (as qualified) in accordance with specific protocols in support of special investigations and projects as directed by Manager.

• BS in biological or chemical sciences required

• A minimum of 5-10 years sterilization validation experience and related microbiological analysis, preferably in a pharmaceutical environment

Special Skills: General laboratory skills, including: handling, dilution, and plating of microbiological specimens using aseptic technique, sterility testing, and operation of sterilizers and data logging equipment. Basic math and computer skills including Microsoft Word and Excel. Knowledge of statistical methods of analysis.

Specialized Training: Possess expertise in sterilization processing. Knowledge and awareness of GMPs/Quality Systems and AAMI/ISO sterilization standards.

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