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 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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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.