Stability Engineer

Ultradent Products • Salt Lake, UT

1d

About The Position

Ultradent, a global name in oral health, is looking for a Stability Engineer . The Stability Engineer is responsible for coordinating stability activities for the organization. Stability is a product’s resistance to degradation throughout its shelf life and is a crucial aspect of product development and quality control. The Stability Engineer develops and implements product stability studies acting as an integrated resource to teams from R&D to Regulatory Affairs. This includes supporting stability activities for new product development and throughout the product lifecycle. Oversees the overall stability program under direction from the Stability Engineering Manager, while working with subject matter experts within R&D and other departments. Writes stability protocols and reports Maintains control and logging in of studies and samples. Interfaces with R&D, Formulation, Quality, Regulatory and other departments regarding stability.

Requirements

• Bachelor’s Degree in engineering or science related field or equivalent work experience
• Minimum of 1 years’ experience directly related to the following areas: stability, excursion studies, storage and shipping conditions, real time testing, accelerated aging, and cold storage testing
• Excellent communication skills, both verbal and written
• Basic understanding of calibration
• Understanding of good laboratory practices in relation to GMP
• Strong organizational skills
• Proficiency with MS Office and other work-related computer software

Nice To Haves

• Strong understanding of FDA regulations and ISO13485 requirements for stability is ideal
• Strong knowledge of ANSI standards pertaining to calibrations
• Ability to speak about stability on a technical level to auditors from FDA, notified body, etc.

Responsibilities

• Develops and implements product stability studies
• Supports stability activities for new product development and throughout the product lifecycle
• Oversees the overall stability program under direction from the Stability Engineering Manager
• Writes stability protocols and reports
• Maintains control and logging in of studies and samples
• Interfaces with R&D, Formulation, Quality, Regulatory and other departments regarding stability

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees