Senior/ Associate Validation Engineer - Medical Device

Tekhawks LLC.; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Tekhawks LLC. seeks Validation Engineers (Assoc. to Senior) to perform hands‑on remediation of validation activities in a regulated medical device environment. You will close gaps, author validation documents, and support audit readiness across IQ/OQ/PQ and process validation.

The role emphasizes on‑site execution and collaboration with Quality, Manufacturing, and Engineering teams to sustain compliant documentation and processes.

Qualifications

• 5–10+ years validation experience in medical device or regulated industry.
• 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.
• 3–5 years experience in validation, quality, or manufacturing.
• Exposure to regulated environments (medical device preferred).
• Experience supporting validation execution or documentation.
• Strong attention to detail.

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.

Skills

IQ/OQ/PQ execution

Validation

Regulated industry

Documentation

Quality systems

Job description

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

• 5–10+ years validation experience in medical device or regulated industry
• 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
• 3–5 years experience in validation, quality, or manufacturing
• 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