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Brooksource · 18 hours ago

Risk Assessment Validation Engineer

Gaithersburg, MD

Full-time

Hybrid

Mid, Senior Level

Brooksource is seeking a Risk Assessment Validation Engineer to support a critical gap in their commissioning and validation strategy. The role involves performing risk-based assessments during commissioning and translating those outcomes into validated states, ensuring compliance with data integrity and product quality standards.

EmploymentHuman ResourcesInformation Technology

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Perform risk-based assessments on individual systems during commissioning

Evaluate impacts to data integrity, product quality, and patient safety

Determine when validation is truly required based on risk

Translate commissioning outcomes into targeted validation evidence

Produce clear, audit-ready documentation and rationale

Support a mature, risk-based validation model (beyond simple direct/indirect classification)

Qualification

GxP validation principlesSystem-level risk assessmentsAudit-ready documentationRisk-based validation modelCollaboration skills

Required

Strong understanding of GxP validation principles

Hands-on experience performing system-level risk assessments

Ability to independently conduct assessments, document rationale, and defend decisions

Comfortable working with external commissioning partners while owning the risk layer

Able to challenge or refine existing requirements using risk logic

Company

Brooksource

Glassdoor4.0

Brooksource is a single source for project and supplemental support through contract employment, contract-to-hire labor employment.

Founded in 2000

Indianapolis, Indiana, USA

1001-5000 employees

http://www.brooksource.com

H1B Sponsorship

Brooksource has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (10)