Senior Systems Validation Specialist

Our client is looking for a highly experienced Senior Systems Validation Specialist to lead the development and deployment of a new validation system. This role is crucial to digitizing and streamlining the manufacturing and quality processes across our entire site.

We're seeking a candidate with a strong background in the medical device industry, specifically in Manufacturing, Quality, or New Product Introduction.

Key Responsibilities

• Manage the full lifecycle of the new app's software validation, from authoring requirements to approving final reports.
• Create comprehensive user manuals and troubleshooting guides, then lead the site-wide rollout and provide hands-on training to various teams.
• Support the application post-deployment, including troubleshooting and continuous improvement efforts. While not a prerequisite, previous experience as a CAPA owner is desirable.

What we're looking for:

• 5+ years of experience in the medical device industry in a relevant role (Manufacturing, Quality, or New Product Introduction).
• Degree in Engineering, Quality, or a related discipline.
• Demonstrated experience with software validation for a custom application or software package.
• Proven ability to manage the site-wide rollout of a software solution to a large user base (1,500+ users).
• Strong technical writing skills with the ability to create clear, comprehensive user documentation for diverse audiences.

This is a unique opportunity for an experienced Manufacturing or Quality Engineer to make a significant impact by leading a critical project that will transform our operational efficiency.