Computer Systems Validation Engineer

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150k - $178k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 19%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Lead and scale the Computer System Validation capability across IT, defining the validation strategy, operating model, standards, and risk-based approach • Build and develop the CSV team, including hiring, onboarding, mentoring, and developing additional CSV Engineers • Author, review, execute, and maintain validation lifecycle deliverables, including validation plans, requirements, risk assessments, specifications, test protocols and scripts, traceability matrices, and validation summary reports • Determine validation scope, test depth, and evidence requirements using a documented risk-based approach • Execute or coordinate qualification and verification activities, including installation, operational, performance, user acceptance, and other risk-based assurance testing • Assess changes to validated systems, determine validation impact, support regression testing, and ensure approved change control implementation • Perform validation maintenance, periodic reviews, access and audit-trail reviews, revalidation assessments, and retirement or decommissioning support • Support investigation and resolution of validation deviations, test exceptions, incidents, and compliance gaps, contributing to CAPAs when appropriate • Prepare validation records and evidence packages for audits, regulatory inspections, and due-diligence activities • Collaborate with system owners, business process owners, Quality, IT, technical teams, and vendors • Continuously improve validation procedures, templates, standards, metrics, and training materials • Use approved automation and AI-assisted tools to improve validation efficiency while independently reviewing outputs

🎯 Requirements

• Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered • Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment • Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles • Demonstrated ability to lead validation activities across multiple computerized systems and projects • Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation • Strong knowledge of GxP requirements, GAMP 5, risk-based CSV/CSA principles, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, change control, deviations, CAPA, and document control • Experience with functional risk assessments, requirements traceability, supplier assessments, change control, deviations, CAPA, and periodic review • Experience authoring, reviewing, or executing IQ, OQ, PQ, UAT, or equivalent risk-based verification documentation • Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is advantageous • Regular use of a computer, devices, or other office equipment, clear communication, and occasional movement

🏖️ Benefits

• Equal opportunity employer • Reasonable accommodations for individuals with disabilities • Occasional travel as needed