Principal Validation Engineer - Medical Device #4149

Brief DescriptionAbout ECIECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.About The RoleWe are seeking an experienced Principal Validation Engineer with 10+ years' experience to lead validation strategy and execution for medical device products, manufacturing processes, equipment, facilities, and computerized systems. This role provides technical leadership across cross-functional teams and ensures compliance with FDA, ISO 13485, EU MDR, and global regulatory requirements. The ideal candidate combines deep validation expertise with strong project leadership and mentoring capabilities.What You'll DoDevelop and execute validation protocols and reports.Validate manufacturing equipment, processes, software systems, and test methodsSupport process validation for new product introductions and process changesPerform risk assessments and support CAPA activitiesReview engineering changes for validation impactCollaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and suppliersAnalyze validation data and prepare technical documentationParticipate in audits and inspectionsMaintain validation master plans and documentation systemsWhat We Look ForAVI / Visual Inspection Expertise Automatic Visual Inspection (AVI) systems validationManual Visual Inspection (MVI) program knowledgeExperience with:Knapp systems strongly preferredSeidenader, Antares, Eisai, or similar acceptableTwo-stage inspection strategies (AVI + MVI)Validation ExperienceIQ/OQ/PQ execution and reviewPPQ interpretation and supportSeeded defect studiesDefect detection rate analysisAQL sampling and acceptance criteriaPharma / Inspection ScienceSterile injectable or parenteral manufacturing experienceUSP and USP familiarityVisual inspection defect standards and qualification methodologyRegulatory / Risk AssessmentFDA-facing validation documentation experiencePrior Approval Supplement (PAS) support preferredAbility to assess regulatory impact/risk of validation findingsExperience supporting audits, inspections, or regulatory submissionsAll qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.