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 ;br>
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 ;br>
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).

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ;br>
The anticipated base pay range for this position is 125,000-175,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - This job posting is anticipated to close on August 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.