Validation Engineer

Hello,

I hope you're doing well.

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for an Validation Engineer based in Boston, MA with one of our prestigious clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com

Role: Validation Engineer
Location: Boston, MA

Overview
This engagement supports a large-scale Quality Management System (QMS) remediation for a medical device organization under FDA oversight. The initiative focuses on closing gaps and driving compliance with 21 CFR Part 820 and ISO 13485 across key quality areas including validation, CAPA, complaints, and design controls.
The program is audit-driven and requires strong onsite execution, with an emphasis on documentation remediation, inspection readiness, and sustainable compliance improvements.

Position Summary
Seeking Validation Engineers (Associate through Senior level) to support execution-heavy validation remediation activities. This is a hands-on role focused on closing validation gaps and remediating documentation in a regulated manufacturing environment.

Responsibilities

• Execute and remediate validation activities (IQ/OQ/PQ, process validation)
• Identify and close compliance gaps against FDA and ISO requirements
• Update and remediate legacy validation documentation
• Author protocols, reports, and summary documentation
• Partner with Quality, Manufacturing, and Engineering teams
• Support audit readiness and inspection activities

Qualifications

• 3 5 years experience in validation, quality, or manufacturing.
• Strong hands-on experience executing and authoring IQ/OQ/PQ
• Deep knowledge of 21 CFR Part 820 and ISO 13485
• Experience with remediation or audit-driven programs
• Exposure to regulated environments (medical device preferred)
• Experience supporting validation execution or documentation
• Strong attention to detail

Preferred

• FDA inspection, warning letter, or remediation experience
• CSV / Part 11 exposure
• Experience with high-volume documentation remediation