Validation Engineer 3

Job Title: Validation Engineer 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 7+ 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 #M3 #LI-MM1 Ref: #558-Scientific

Full Time