Validation Engineer 3

Company: Joul--
Location: Littleton
Posted on: May 2, 2025

Job Description:

Job Title: Validation Engineer

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
Location: Lakewood, CO (Onsite - relocation assistance available)
Compensation: $107,000 - $133,800 annually + 7% Annual Bonus
Type: Full-Time, Direct Hire

Overview:
Join a globally recognized leader in medical technology that specializes in life-saving devices used in blood donation and plasma separation. This Validation & Quality Engineer 3 role supports a high-impact, stable business unit working on a brand-new product that's entering an entirely new market for the company. Be part of a mission-driven team contributing to innovation and plays a critical role in healthcare worldwide.

Responsibilities:

Lead validation projects, including authoring and executing Validation Master Plans (VMP), Installation (IQ), Operational (OQ), and Performance Qualifications (PQ)
Execute and document test method validation protocols, conduct statistical analysis, and ensure compliance with internal procedures
Support validation activities from approved suppliers, ensuring records meet regulatory and corporate standards
Perform periodic reviews of automated equipment, computerized systems, and test instruments
Independently evaluate and adapt technical solutions for complex validation and quality engineering problems
Serve as project lead on high-complexity projects, overseeing total execution
Conduct root cause analyses and lead CAPA/NC resolution efforts
Collaborate across functions to maintain compliance with FDA, ISO 13485, and GMP requirements


Requirements: Minimum 4+ years of validation and quality engineering experience in the medical device industry
Demonstrated experience with IQ/OQ/PQ, process validation, and test method validation
Working knowledge of FDA regulations, ISO 13485, GMP, and validation documentation
Proficient in risk management tools such as FMEA
Strong background in CAPA and NC processes, including investigative and corrective actions
Technical expertise in areas such as fluids engineering, mechanical/chemical systems, and cellular biology
Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or a relevant scientific field

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Ref: #558-Scientific

Keywords: Joul--, Boulder , Validation Engineer 3, Engineering , Littleton, Colorado