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Operations Reliability Scientist

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salt lake city, ut • Posted 1 weeks ago

Onsite Full Time Other

Overview

BioFire Defense, LLC, 79 West 4500 South, Salt Lake City, Utah, United States of America

Job Title: Operations Reliability Scientist

Reporting Relationships

Direct Supervisor: VP of Operations

Responsibilities

Lead data analysis, investigations, and information related to product performance within the Operations Department.
Direct cross-functional teams for product failure investigations to determine potential product impact, identify root causes, and implement corrective and preventative actions in accordance with established procedures.
Monitor and report on product trends for operational and product performance-related stakeholders; provide technical guidance on product and process risk to support and project teams.
Identify and implement process improvement opportunities; routinely interface with R&D to identify trends, failure modes, and risks from production events.
Oversee and execute duties related to product reliability within the team.
Work on problems of diverse scope requiring data evaluation to proactively identify trends or failure modes affecting product performance.
Lead or participate in product reliability investigations related to reagent manufacturing (Quality Events, SPC trends, project-related).
Initiate and lead CAPAs related to manufacturing for product reliability; perform root cause analysis and apply corrective and preventative actions.
Engage cross-functionally with other departments during investigations and for process improvement projects.
Identify and report on existing and emerging trends and investigations related to process and product performance to Operations and Defense Leadership Teams and regulatory bodies as required.
Identify and report on trends, investigations, and quality events related to processes and products to Operations management and Defense Leadership Teams.
Manage departmental metric data related to the product performance process and report to stakeholders.
Apply technical writing and presentation skills to document product knowledge and recommendations regarding non-conformances and investigations in accordance with the Quality Management System.
Exercise judgment within defined practices to select methods and techniques; typically require limited instruction on routine work and general instruction on new assignments.
Provide process and product technical guidance to program managers and engineers, including training/mentoring manufacturing leaders.
Act as the technical expert on reagent chemistry interactions within the Operations department.
Serve as primary technical liaison between R&D, Regulatory, Quality, and manufacturing operations.
Attend project phase gates as needed and review project plans that impact process and product.
Perform all work in compliance with company quality procedures and standards.
Identify and implement process improvement opportunities with support from the Industrialization and Tech Transfer teams.
Administer, manage, and lead a team focused on product reliability, process improvement, and early identification of potential product performance issues related to processes, personnel, environment, raw materials, and automation interfaces.
Performs other duties as assigned.

Qualifications

Training and Education: (Minimum education and/or training requirements for this position; i.e., high school diploma, college degree, certification.)

MS degree in Biochemistry, Chemical Engineering, or other science-related program required.
PhD degree in Biochemistry, Chemical Engineering, or other science-related program preferred.

Experience: (Minimum time and type experience required for this position.)

4-5 years’ experience in troubleshooting, project planning, execution, scientific rigor, investigation, and process improvement.
Familiarity with a QMS, regulatory, cGMP environment.
Experience as a Project or Program Manager preferred.

Skills: Special skills required such as technical writing, statistical evaluation; data analytics; critical thinking; analytical and problem-solving skills.

Physical Requirements: None

Review

I have reviewed this job description with my supervisor. I understand my responsibilities and I meet the minimum requirements listed above. I have provided BioFire Defense’s Human Resources Department with documented evidence (e.g., resume, diplomas, employment verification) that I meet the listed qualifications.

Benefits and Miscellaneous

9/8/80 work schedule (every other Friday off).
401k with company match up to 5% (up to 9.5% with full participation).
160 hours of PTO (prorated from date of hire).
9 paid holidays.
Paid Winter Break (Dec 24–31).
Participation in the Wellness Program (discounted medical premiums).
Various company-sponsored events and amenities (catered meals, snacks, free parking).
Convenient location near I-15 and Trax Station.
Our EEO Policy: BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to protected characteristics in accordance with law.