Validation Engineer

Validation Engineer / Project Engineer (Medical Device)

Johnson & Johnson Medtech

Location: San Angelo, TX (Hybrid - alternating onsite and remote weeks)

Experience: ~5+ years

Overview

We are seeking an experienced Validation Engineer with strong project engineering skills to support a critical manufacturing change for a medical device product. This is a highly cross‑functional role focused on both project management (approximately 70%) and hands‑on validation engineering (approximately 30%).

The project involves a change in suture manufacturing, specifically transitioning how a sterilization agent is incorporated into the product. This role will be instrumental in developing and executing validation strategies from the ground up while coordinating closely with R&D, Quality, and Operations.

Key Responsibilities

Project & Program Management (Primary Focus):

• Lead and manage a complex manufacturing change project from validation planning through execution.
• Drive change control activities, ensuring documentation, redlines, and approvals are current and compliant.
• Coordinate cross‑functional responsibilities, timelines, and deliverables across Operations, Quality, and R&D.
• Ensure appropriate sampling strategies, documentation readiness, and hold points are clearly defined and followed.
• Communicate project status, risks, and mitigation plans to stakeholders.

Validation Engineering:

• Develop validation strategies and author validation documentation from scratch, including IQ, OQ, and PQ.
• Execute validation activities in a regulated medical device manufacturing environment.
• Review and assess manufacturing processes and procured equipment to determine validation requirements.
• Analyze validation data and compile final reports in compliance with regulatory and quality standards.
• Partner closely with Quality to ensure validation approaches meet internal and external requirements.

Cross‑Functional Collaboration

• Work closely with internal R&D teams located at multiple U.S. sites to ensure alignment between manufacturing execution and development intent.
• Serve as a bridge between manufacturing sites and R&D, ensuring feedback and data are communicated effectively.
• Collaborate with Operations and Quality teams to support seamless implementation of manufacturing changes.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of experience in validation engineering within a medical device or highly regulated environment.
• Strong working knowledge of IQ/OQ/PQ development, execution, and reporting.
• Experience managing manufacturing changes and associated validation activities.
• Demonstrated ability to lead projects, manage timelines, and coordinate cross‑functional teams.
• Excellent documentation, communication, and organizational skills.

Preferred Background

• Combination of Project Manager or Project Engineer experience with a solid validation foundation.
• Experience authoring validation protocols that did not previously exist.
• Ability to work independently and drive initiatives with minimal oversight.
• Comfortable balancing hands‑on technical work with high‑level project oversight.

Additional Details

• Hybrid work model: one week onsite followed by one week remote.
• Interview panel includes the hiring manager and Quality representation.
• Opportunity to contribute to a high‑impact manufacturing transformation in a fast‑paced medical device environment.