Principal Validation Engineer - Medical Device #4149

Principal Validation Engineer - Medical Device #4149 Enhanced Compliance Inc. - 3.3 Bedford, MA Job Details Full-time 1 day ago Qualifications Quality control corrective actions Regulatory inspections Technical documentation ISO standards Corrective and preventive actions (CAPA) Mentoring Vision inspection system Regulatory submissions Industrial equipment Manufacturing Senior level Regulatory audits Cross-functional collaboration Project leadership Cross-functional team management Leadership Regulatory compliance management FDA regulations Engineering validation 10 years Full Job Description About ECI ECI'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 Role We 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 Do Develop and execute validation protocols and reports. Validate manufacturing equipment, processes, software systems, and test methods Support process validation for new product introductions and process changes Perform risk assessments and support CAPA activities Review engineering changes for validation impact Collaborate with Quality, Manufacturing, R D, Regulatory Affairs, and suppliers Analyze validation data and prepare technical documentation Participate in audits and inspections Maintain validation master plans and documentation systems What We Look For AVI / Visual Inspection Expertise Automatic Visual Inspection (AVI) systems validation Manual Visual Inspection (MVI) program knowledge Experience with: Knapp systems strongly preferred Seidenader, Antares, Eisai, or similar acceptable Two-stage inspection strategies (AVI + MVI) Validation Experience

IQ/OQ/PQ

execution and review PPQ interpretation and support Seeded defect studies Defect detection rate analysis AQL sampling and acceptance criteria Pharma / Inspection Science Sterile injectable or parenteral manufacturing experience USP and USP familiarity Visual inspection defect standards and qualification methodology Regulatory / Risk Assessment FDA-facing validation documentation experience Prior Approval Supplement (PAS) support preferred Ability to assess regulatory impact/risk of validation findings Experience supporting audits, inspections, or regulatory submissions 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 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.