CooperCompanies

CooperCompanies

·11 days ago

Sr. computer systems validation engineer

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Location

remote, United States

Commitment

Full Time

Level

Senior (5+ years)

Required skills

Computer Systems ValidationSoftware Quality AssuranceQuality Management SystemsSDLCChange ManagementGxPRisk AssessmentFDA 21 CFR Part 11GAMPISO 13485ISO 14971Agile PLMMasterControlVeevaTrackWiseMicrosoft D365

Job Description

Scope:

The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations.

Job Summary:

The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.

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