Validation Specialist

🔥 22 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $80k - $115k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead computerized system validation (CSV) activities for regulated applications throughout the SDLC • Develop, review, and approve validation plans, risk assessments, test strategies/scripts, traceability matrices, deviations, and validation summary reports • Partner with Quality Assurance, IT, Business Analysts, system owners, vendors, and project teams • Review requirements, specifications, configurations, vendor documentation, and change controls • Define and oversee risk-based testing strategies and ensure validation evidence is complete, accurate, traceable, and inspection-ready • Assess system changes and determine validation scope based on risk, intended use, and regulatory requirements • Investigate validation deviations, test failures, and system-related quality issues, including compliance and data integrity impact assessments • Support internal, sponsor, and regulatory audits and inspections as a validation subject matter expert • Provide technical guidance and peer review to validation and project team members • Contribute to continuous improvement of validation procedures, templates, standards, and governance practices

🎯 Requirements

• Bachelor's degree in computer science, Information Systems, Life Sciences, Engineering, Quality, or a related discipline • 5+ years of progressive experience in computerized system validation, computer software assurance, software quality, or validation within a regulated environment • Experience independently leading complex validation activities and providing technical direction to cross-functional teams • Experience supporting GxP-regulated systems, preferably within pharmaceutical, biotechnology, CRO, medical device, laboratory, or healthcare environments • Experience with Agile, Waterfall, or hybrid SDLC methodologies • Experience with risk assessments, change control, deviation management, requirements traceability, testing, and maintenance of validated systems • Strong knowledge of CSV principles and computerized system lifecycle management • Strong knowledge of FDA 21 CFR Part 11, GAMP 5, GxP, ALCOA+, data integrity, and risk-based validation methodologies • Familiarity with Computer Software Assurance (CSA) principles and contemporary risk-based assurance approaches • Strong analytical, problem-solving, documentation, and technical writing skills • Ability to critically review validation and technical documentation and identify compliance, quality, and data integrity risks • Ability to manage multiple complex projects and priorities with limited supervision • Proficiency with Microsoft Office • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including drug screening • Able to communicate, receive, and understand information and ideas with diverse groups of people • Able to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology with proficiency • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

🏖️ Benefits

• Fully remote, home-based role • Variable annual bonus based on company, team, and/or individual performance • As-needed travel of 0–20% • Relocation assistance is not provided