Validation Engineer 3 (contingent)

System One; Lakewood (CO); On-site; Full time

Job summary

A leading company in medical technology is seeking a Validation Engineer 3 for a 9-month contract in Lakewood, CO. This role involves leading validation projects, ensuring compliance with regulatory standards, and contributing to innovative healthcare solutions. The ideal candidate will have extensive experience in validation engineering within the medical device industry and a strong technical background.

Qualifications

• 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.

Responsibilities

• Lead validation projects, including authoring and executing Validation Master Plans.
• Conduct root cause analyses and lead CAPA/NC resolution efforts.
• Collaborate across functions to maintain compliance with FDA, ISO 13485, and GMP requirements.

Skills

Validation Engineering

Statistical Analysis

Risk Management

CAPA

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering

Tools

FMEA

Job description

Job Title: Validation Engineer 3
Location: Lakewood, CO
Compensation: $53– $66.50per hour
Type: 9 month contract

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