Validation Engineer 4 (contingent) Position Available In Pettis, Missouri
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Job Description
Job Description:
Job Title:
Validation Engineer 4
Location:
Onsite in
Littleton,CO Compensation:
$70-$85/hr
Type:
9 month contract
Overview:
Join aglobally recognized leader in medical technology that specializesin life-saving devices used in blood donation and plasmaseparation. This Validation & Quality Engineer 3 role supports ahigh-impact, stable business unit working on a brand-new productthat’s entering an entirely new market for the company. Be part ofa mission-driven team contributing to innovation and plays acritical role in healthcare worldwide.
Responsibilities:
Leadvalidation projects, including authoring and executing ValidationMaster Plans (VMP), Installation (IQ), Operational (OQ), andPerformance Qualifications (PQ) Execute and document test methodvalidation protocols, conduct statistical analysis, and ensurecompliance with internal procedures Support validation activitiesfrom approved suppliers, ensuring records meet regulatory andcorporate standards Perform periodic reviews of automatedequipment, computerized systems, and test instruments Independentlyevaluate and adapt technical solutions for complex validation andquality engineering problems Serve as project lead onhigh-complexity projects, overseeing total execution Conduct rootcause analyses and lead CAPA/NC resolution efforts Collaborateacross functions to maintain compliance with
FDA, ISO
13485, andGMP requirements
Requirements:
Minimum 8 years of validation andquality engineering experience in the medical device industryDemonstrated experience with IQ/OQ/PQ, process validation, and testmethod validation Working knowledge of FDA regulations, ISO 13485,GMP, and validation documentation Proficient in risk managementtools such as FMEA Strong background in CAPA and NC processes,including investigative and corrective actions Technical expertisein 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
