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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).