Sr. Computer Validation System's Engineer

Ocular Therapeutix(8 days ago)

Bedford, MAOnsiteFull TimeSenior$135,000 - $145,000Validation/Quality

About this role

Ocular Therapeutix is seeking a Senior Computer Systems Validation Engineer to ensure that computerized systems used in manufacturing, laboratory, and enterprise processes comply with industry regulations. The role involves validation, documentation, risk assessment, and supporting audits to maintain compliance within the company's GxP environment.

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Required Skills

validation
GAMP 5
Risk Assessment
CSV
Documentation
FDA Regulations
Quality Systems
IQ
OQ
SAT

Qualifications

Bachelor’s degree in Engineering, Computer Science or related discipline
7+ years of CSV experience in an FDA regulated industry

About Ocular Therapeutix

ocutx.com

Ocular Therapeutix is an ophthalmic biopharmaceutical company focused on developing innovative treatments for retinal diseases. Its lead program, AXPAXLI™, is a sustained‑release hydrogel therapy in development as a potential treatment for wet age‑related macular degeneration (wet AMD), designed to extend drug exposure and reduce injection frequency. The company develops and aims to commercialize ophthalmic products that improve outcomes for people with retinal disease. Ocular Therapeutix combines drug formulation and ocular drug‑delivery technology to redefine treatment approaches in retinal care.

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