- FDA Regulations
- Clinical Trials
Headquartered in Santa Barbara, California, Sientra is a diversified global medical aesthetics company and a leading partner to aesthetic physicians. The Company offers a suite of products designed to make a difference in patients' lives by enhancing their body image, growing their self-esteem, and restoring their confidence. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes.
Our leadership is driven by decades of experience and skill that help bring your goals and aesthetic visions to life. We believe that shared expertise and values are essential components of success. We are seeking exceptionally talented and motivated people to join our team. If you are looking for a career that is both challenging and rewarding, and to work for a company at the forefront of the aesthetic industry, please check out our available opportunities. We look forward to hearing from you!
Essential Duties and Responsibilities
Principal Sterilization Microbiologist will establish and maintain quality engineering methodologies, systems and practices to meet regulatory requirements. Main priorities include providing support for Dry Heat Sterilization process and routine testing of Class 7 cleanroom. The Quality Engineer position is the process owner for Cleanroom qualifications, environmental monitoring programs, cleaning process, sterilization process, internal audits and new product development projects.
Additional Duties and Responsibilities
Develop, implement, manage and improve the Environmental monitoring process to include data trending, excursion investigations, product impact and documentation.
Subject matter expert and technical advisor on cleanroom environment, contamination controls and sterilization processes.
Management of outsources laboratory services (micro, biological indicators, cleaning, sterilization process and microbiological testing.
Supports new product development) activities
Assist in CAPA activities as directed, including complaint failure investigations and customer communications
Role is subject matter expert on Sterilization Process (sterilizer IQ, OQ and PQ validation ) and ongoing routine re-qualifications as required per industry sterilization standards and guidelines
Responsible for review of sterilization cycle data and product release
Other duties as assigned.
This position has no supervisory responsibilities
Requirements (Education, Certificates, Licenses, Registrations, etc.)
A minimum of a bachelor’s degree in biology or science
A minimum of 3 years of experience working in a FDA or ISO regulated environment or equivalent
Experience with statistical process control and process validation
Ability to analyze information and act on results
Ability to work well with people at all levels within the organization
Accuracy and attention to detail
This description contains the essential functions necessary to evaluate the position. It is not intended and should not be used as an exhaustive list of all responsibilities, skills or efforts.
FLSA Status: Exempt
If you would like to apply for this position, please email your resume to email@example.com.