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Validation Engineer

Belcan Corporation
United States, California, Thousand Oaks
Jan 28, 2025

Details:

Job Title: Validation Engineer
Location: Thousand Oaks, CA
Zip Code: 91320
Start Date: Right Away
Job Type: Contract
Pay Rate: $37 / hr
Keywords: #Engineer #EngineeringJobs

JOB RESPONSIBILITIES:
* Support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization.
* Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.
* Assist with project definition by performing engineering studies and assessment for automated test systems installations.
* Perform field evaluations of existing systems and provide engineering design recommendations.
* Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
* Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
* Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
* Developing, enhancing, automating, and managing test data
* Network with manufacturing and quality organizations
* Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
* Monitoring technological developments in the field & evaluation of new technologies

REQUIRED QUALIFICATIONS:
* Master degree OR Bachelor degree and 2 years of experience
* Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
* Mathematical background fundamentals of statistics
* Ability to manage multiple, competing priorities simultaneously
* 3 years experience in field. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired
* Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling.
* Nice to have programming R and python experience hands on technical experience useful, comfortable working within a lab.

PREFERRED QUALIFICATIONS:
* Experience working in a regulated industry, exposure to GMPs
* Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
* Statistical analysis, and knowledge of Gage R&R,
* Knowledge of Optical measurement devices, force testers, BLE testing
* Test method development, CAD design, Solidworks, mechanical modeling
* Manufacturing experience, IQ, OQ, and PQ
* Ability to manage multiple, competing priorities simultaneously, experience with MS Project

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans


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