Validation Engineer
Not Disclosed•ContractorOn-site
location_on111, Park Drive, Fenway, Boston, Suffolk County, Massachusetts, 02115, United States
About the Opportunity
Intellectt Inc. is presenting a contract opportunity for a Validation Engineer to support a large-scale Quality Management System (QMS) remediation for a prestigious medical device client in Boston, MA. This engagement operates under strict FDA oversight, focusing on closing compliance gaps and driving adherence to 21 CFR Part 820 and ISO 13485 across validation, CAPA, complaints, and design controls.
About the Role
This is a hands-on, execution-heavy role designed for Associate through Senior level engineers. The position centers on closing validation gaps and remediating documentation within a regulated manufacturing environment. As a key member of the team, you will partner with Quality, Manufacturing, and Engineering groups to update legacy validation documentation, author protocols and reports, and ensure the organization remains audit-ready. The program is driven by the need for inspection readiness and sustainable compliance improvements, requiring strong onsite execution and a meticulous attention to detail.
Work location
Work model: On-site
111, Park Drive, Fenway, Boston, Suffolk County, Massachusetts, 02115, United States
Boston, Massachusetts
Key Responsibilities
- check_circleExecute and remediate validation activities including IQ, OQ, and PQ
- check_circleIdentify and close compliance gaps against FDA and ISO requirements
- check_circleUpdate and remediate legacy validation documentation
- check_circleAuthor validation protocols, reports, and summary documentation
- check_circlePartner with Quality, Manufacturing, and Engineering teams
- check_circleSupport audit readiness and inspection activities
Requirements
- verified3-5 years experience in validation, quality, or manufacturing
- verifiedStrong hands-on experience executing and authoring IQ/OQ/PQ
- verifiedDeep knowledge of 21 CFR Part 820 and ISO 13485
- verifiedExperience with remediation or audit-driven programs
- verifiedExposure to regulated environments (medical device preferred)
- verifiedExperience supporting validation execution or documentation
Nice to Have
Experience with FDA inspection, warning letter, or remediation. CSV / Part 11 exposure. Experience with high-volume documentation remediation.
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Frequently asked questions about Validation Engineer at Intellectt Inc
What does a Validation Engineer at Intellectt Inc do?expand_more
In this Validation Engineer at Intellectt Inc role, you will execute and remediate validation activities including iq, oq, and pq; identify and close compliance gaps against fda and iso requirements; update and remediate legacy validation documentation; and author validation protocols, reports, and summary documentation.
What are the requirements for this Validation Engineer role?expand_more
Intellectt Inc is looking for candidates who meet the following requirements: 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); and Experience supporting validation execution or documentation.
Where is the Validation Engineer role at Intellectt Inc located?expand_more
Validation Engineer at Intellectt Inc is based in 111, Park Drive, Fenway, Boston, Suffolk County, Massachusetts, 02115, United States. This is a on-site role.
Is this Validation Engineer job remote, hybrid, or on-site?expand_more
Intellectt Inc has listed this Validation Engineer role as on-site.
How much experience is required for this Validation Engineer role?expand_more
Validation Engineer at Intellectt Inc typically requires 3–5 years of relevant experience at the mid level level.
What skills do you need for the Validation Engineer role at Intellectt Inc?expand_more
Key skills for Validation Engineer at Intellectt Inc include Iq/oq/pq; Process Validation; 21 CFR Part 820; Iso 13485; Capa; CSV; and Part 11.
What category does the Validation Engineer role belong to?expand_more
Validation Engineer at Intellectt Inc is part of the engineering job category on Recrutus.