Validation Specialist – Quality Systems, ETQ Reliance

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $89.6k - $198.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 7%

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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LouisianaNOW.Jobs

WebsiteLinkedInAll Job Openings

51 - 200 employees

🎯 Recruiter

🏪 Marketplace

Recruitment • Marketplace

LouisianaNOW. Jobs is a regional jobs portal and talent attraction site focused on connecting job seekers to employers and economic opportunities across Louisiana. The site highlights regional communities, industry sectors, current employers who are hiring, career advice articles, and job listings, and appears to be operated or supported by LED FastStart (Louisiana Economic Development). It’s positioned as a marketplace that promotes Louisiana’s growing industries and helps match talent with local openings and employer investment announcements.

📋 Description

• Lead validation efforts for ETQ Reliance implementations, upgrades, enhancements, and integrations • Develop and execute validation plans, URS, functional specifications, risk assessments, IQ, OQ, PQ, traceability matrices, and validation summary reports • Ensure compliance with FDA, GxP, 21 CFR Part 11, and applicable regulatory requirements • Partner with Quality, Manufacturing, and IT teams to define system requirements and validation strategies • Support configuration, workflow validation, testing, and release management activities within ETQ Reliance • Conduct risk-based validation assessments and recommend compliance strategies • Ensure computerized systems remain in a validated state throughout their lifecycle • Collaborate within Agile project teams through sprint planning, backlog refinement, testing, and release activities • Support data migration validation and system integration testing activities • Work with Quality, IT, business stakeholders, and vendors on quality application implementation, enhancement, validation, and maintenance • Utilize SDLC and Agile methodologies • Contribute to CGI's IT and business consulting services for clients

🎯 Requirements

• 5+ years of Computer System Validation (CSV) experience within Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or regulated environments • 3+ years of hands-on ETQ Reliance experience • Strong expertise in Quality Management Systems (QMS) • Extensive knowledge of FDA Regulations • Extensive knowledge of GxP Requirements • Extensive knowledge of 21 CFR Part 11 • Extensive knowledge of Data Integrity Principles • Extensive knowledge of Computer System Validation Methodologies • Experience developing validation deliverables from requirements through release • Experience supporting software development projects utilizing SDLC methodologies • Experience working in Agile and Scrum environments • Strong understanding of software testing methodologies, defect management, and release processes • Excellent technical writing, documentation, and communication skills • Ability to work independently and manage multiple priorities simultaneously • Experience validating cloud-based applications and SaaS platforms • Knowledge of GAMP 5 guidance and risk-based validation approaches • Experience with CAPA Management, Change Management, Deviations, Audit Management, Document Control, Training Management, and Supplier Quality • Experience with regulated system integrations and data migration projects • ETQ Reliance Configuration and Validation • Computer System Validation (CSV) • Quality Management Systems (QMS) • FDA Compliance & Requirements • SDLC Methodologies • Agile/Scrum Frameworks • Requirements Management • Risk Assessments • Test Script Development & Execution • Defect Tracking and Resolution • Audit Readiness and Compliance • Ability to successfully complete a background investigation • U.S. employment offers may be subject to credit checks depending on assignment and security-clearance requirements

🏖️ Benefits

• Competitive compensation • Comprehensive insurance options • Matching contributions through the 401(k) plan and the share purchase plan • Paid time off for vacation, holidays, and sick time • Paid parental leave • Learning opportunities and tuition assistance • Wellness and Well being programs • Ownership opportunities from day 1 • Global capabilities and industry and technology expertise • Career development and skill-building opportunities • Reasonable accommodations for qualified individuals with disabilities