Process Validation Engineer
Location: Boston, MA
Duration: 12+ Months
Pay Rate: $45/hr-$48/hr on W2
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
Senior Level:
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
Associate Level:
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
Benefits: This a contract position does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to
race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States