Validation Engineer – Medical Devices (IQ/OQ/PQ)

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

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.