Validation Engineer 4 (contingent)

Job Title: Validation Engineer 4

Location: Onsite in Littleton, CO

Compensation: $70-$85/hr

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 8+ 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

Ref:

Permanent