Validation Engineer 4 (contingent)
Location: Sedalia
Posted on: June 23, 2025
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Job Description:
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 M3 LI-MM1
Ref: 558-Scientific
Keywords: , Castle Rock , Validation Engineer 4 (contingent), Engineering , Sedalia, Colorado
