Principal Validation Engineer

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:

Johnson & Johnson is currently seeking a Principal Validation Engineer to join our Heart Recovery team located in Danvers, MA.

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/.

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 exper...