San Diego, California, *Please check our career site (career page at cuehealth.com) - we have many Quality Engineering roles open for hire now! We are also hiring for Manufacturing Quality, Quality Eng, Bioproduction (Bio-Chem), various shifts!
Cue Health Inc. has an opening for a Validation Engineer, Quality Engineering to partner with our Product Development and Manufacturing team’s initiatives and maintain QMS compliance with the applicable Standards and Regulations. Under the guidance of the Manager, Quality Engineering, the Validation Engineer, Quality Engineering, fulfills a critical role in GMP and GLP operations. This individual must plan, write and execute Engineering studies and validation protocols, reports and other technical documents, as well as conduct validation related investigation for our laboratories and manufacturing processes, rooms and equipment. This position requires knowledge of process validation principals, manufacturing controls, and their application to Medical device/IVD standard requirements.
Work in compliance with Cue Health’s Quality Management System requirements
Plan and execute commissioning and validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports
Prepare and/or review functional and design specifications, engineering studies, validation protocols (IQ/OQ/PQ), validation reports and manufacturing documents (standard operating procedures, work instructions, etc.).
Execution of test protocols, including identification and resolution of non-conformances / deviations.
Program and use data loggers for executions of validation protocols.
Support processes, rooms and equipment improvement projects that require validation support
Perform functional and process risk assessments in conjunction with Quality, Operations and Engineering subject matter experts
Perform and document statistical analysis related to validations
Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new processes, rooms and equipment, and/or improvements
Protocols may consist of any of the following: hvac, facilities, utilities, temperature chambers, environmental mapping, and/or mechanical systems
Review and approve validation protocols and reports provided by internal teams or third party suppliers (consultants, equipment / instrument manufacturers, etc.)
Train Operations or laboratory staff on protocols, procedures and technical details related to systems, equipment
Provide consultation to other departments performing validation activities
Manage contractors supporting validation projects
Manage validation equipment in compliance with Quality System Requirements
Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions
Identify areas and opportunities to improve manufacturing facilities, processes, and equipment
Other duties as assigned
Bachelor’s degree in biochemical engineering, mechanical engineering, industrial engineering, or equivalent
5+ years of validation experience in a biotech, medical device, IVD or pharmaceutical product manufacturing environment
Strong knowledge and working application of validation principles, regulatory agency guidelines and standard industry practices.
Knowledge and working application of FDA, ISO 13485 and cGMP requirements
Experience in the biotech, medical device, IVD and/or pharmaceutical industry in the development and deployment of manufacturing processes, process controls, and continuous improvement methods
Ability to deliver results under minimum supervision to accomplish goals while working across departments is required
Demonstrated strong analytical problem solving and team collaboration skills
Excellent interpersonal, written, and verbal communication skills
Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics, etc.
Adaptable to fast-paced, dynamic work environment with ability to methodically manage projects
Sedentary work that primarily involves sitting/standing for prolong periods of time
Adjusting, moving or lifting objects up to 30 pounds
Repeating motions that may include the wrists, hands and/or fingers
You may be requested to operate machinery on occasion
*Please check our site - we have many Quality Engineering roles open for hire!
You will work in an manufacturing environment. Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, competitive salary.
*Please check our site - we have many Quality Engineering roles open for hire! Salary determination will depend on experience, background, industry knowledge & expertise