Validation Engineer I

This is an 11-month contract with a potential for extension, located in Lafayette, CO. W2 contract, no PTO, no benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Responsibilities

• Designs, develops, and implements testing methods and equipment.
• Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices.
• Provides test area with parameters for sample testing and specifies tests to be performed.
• Compiles data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements.
• Responsible for testing all customer samples and for special tests that cannot be performed in the test area.

Requirements

• 1-2 years of experience with testing and data analysis, creating test protocols and reports.
• 2-3 years' experience with Sterilization Validation/Microbiology is desirable.
• Cleaning Validation experience.
• Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, and/or validation reports.
• Ability to work in a fast-paced environment with optimal critical thinking skills and a collaborative mindset.
• Hands-on EO validation sterilization experience and a working knowledge of ISO 11135:2014, ISO 10993-7:2008/AMD 1: 2019, and ISO 11737 series.
• Must be a technical leader, able to handle a project with little to no oversight.

Skills

• Verification and Validation Protocol and Report Execution and Documentation: Translating requirements into repeatable test protocols, executing testing, documenting results, and understanding concepts like sample-size, TMV, and acceptance criteria.
• Technical Problem Solving: Experience analyzing test data, troubleshooting failures, and determining root cause.
• Reprocessing and Sterilization Testing: Ability to safely execute reprocessing involving autoclave sterilization and assess the impact of processing on product performance.
• 3D CAD Modeling (nice to have).

Qualifications

• Bachelor’s in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or another related engineering/technical discipline.
• 1-2 years of relevant experience.

Pay

$34.00 - $44.00/hr