Computer Systems Validation Engineer

Job not on LinkedIn

🔥 19 hours ago

🇺🇸 United States – Remote

💵 $80k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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.

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

💰 Grant on 2021-11

Food & Beverage • Healthcare • Logistics

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Plan, execute, and maintain validation activities for computerized systems in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and applicable GxP regulations • Develop and maintain validation documentation, including Validation Plans, User Requirements Specifications, Functional Specifications, Risk Assessments, Test Cases, Traceability Matrices, and Validation Summary Reports • Perform system risk assessments to determine validation scope and testing requirements • Ensure systems remain in a validated state through periodic reviews, change control, and lifecycle management • Review software releases, upgrades, patches, and configuration changes for validation impact • Develop standard operating procedures, work instructions, and validation templates • Participate in regulatory inspections, customer audits, and internal quality audits • Partner with Quality Assurance, Information Technology, Clinical Operations, and business stakeholders to maintain system fitness for intended use, data integrity, security, and regulatory compliance

🎯 Requirements

• Strong knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU CTR 536/2014, data integrity rules, and software development life cycles • Highly organized and able to manage multiple priorities in a fast paced environment • Minimum high school diploma or GED required • 4+ years of direct CSV experience in a regulated life sciences or clinical research field • Hands-on experience with validation of life sciences/clinical applications (e.g. QMS, CTMS, LIMS, eSource, eBinder) • Must be able to use keyboards and other computer equipment • Care Access is unable to sponsor work visas at this time

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match