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Senior Computer Systems Validation Engineer at CooperCompanies

Trumbull, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer Systems Validation, Software Quality Assurance, Quality Management Systems, SDLC, Change Management, GxP, CSV, CSA, FDA 21 CFR, GAMP, ISO 13485, ISO 14971, Agile PLM, MasterControl, Veeva, TrackWise

Industry

Medical Equipment Manufacturing

Description

About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com [http://www.coopersurgical.com]. Work location: Trumbull, CT (on-site) 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 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.

Responsibilities

The Senior Computer Systems Validation Engineer provides strategic leadership for the validation, maintenance, and continuous improvement of computerized systems in regulated environments. This role is responsible for establishing the corporate CSV framework and ensuring regulatory inspection readiness across the organization.