At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Manufacturing Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** **About the Role:** We are seeking a highly experienced and driven **Principal Validation Engineer** to lead process validation initiatives for complex electro-mechanical medical devices. This senior-level role is critical to ensuring product quality and regulatory compliance through robust validation strategies across both manual and automated assembly processes. As a key technical leader, you will define, develop, and execute validation strategies in a fast-paced environment, working cross-functionally with Manufacturing, Quality, R&D, and Regulatory teams. Your deep expertise will help guide strategic decision-making and ensure validation excellence throughout the product lifecycle. **Key Responsibilities:** + **Develop and Lead Validation Strategies** for complex electro-mechanical systems, including manual assembly and automated manufacturing processes (e.g., robotics, PLC-controlled systems). + Serve as the **subject matter expert (SME)** for process validation, ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards. + **Author and review validation documentation** including Validation Master Plans (VMP), protocols (IQ/OQ/PQ), risk assessments, and final reports. + Design and execute validation activities for new equipment, manufacturing lines, and process changes. + Collaborate with Manufacturing and Quality Engineering to ensure validation requirements are integrated into design and production processes. + Lead and mentor junior engineers and validation team members, promoting best practices and continuous improvement. + Support audits and inspections by providing documentation and subject matter expertise. + Use statistical techniques and tools (e.g., DOE, SPC, Minitab) to design robust validation protocols and analyze data. + Drive improvements to validation procedures, tools, and templates based on industry trends and regulatory changes. **Required Qualifications:** + Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related field. + **10+ years of experience** in process validation within the **medical device industry** , with a focus on electro-mechanical systems. + Demonstrated experience leading validation efforts for **both manual and automated assembly processes** . + Strong working knowledge of **FDA, ISO, and GHTF validation requirements** , including IQ/OQ/PQ frameworks. + Proven ability to develop and execute complex validation strategies and risk-based approaches. + Expertise in **statistical analysis** and validation sampling plans. + Excellent communication, documentation, and cross-functional collaboration skills. + Experience supporting audits (FDA, ISO, internal) as a validation SME. **Preferred Qualifications:** + Six Sigma or Lean certification. + Experience with equipment and software validation (21 CFR Part 11 compliance). + Familiarity with product lifecycle management (PLM) and manufacturing execution systems (MES).