Senior Validation Specialist, LIMS

🔥 14 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

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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

• Implement, configure, maintain, troubleshoot, and support Thermo Scientific LIMS products • Develop and execute computer system validation documentation, including requirements, risk assessments, test protocols/scripts, traceability matrices, validation reports, and associated evidence • Perform functional, regression, integration, and user-acceptance testing • Document testing results and investigate test failures and deviations • Ensure systems and documentation meet applicable GxP/GLP and data-integrity requirements • Assess system changes, enhancements, upgrades, and defects for validation impact and coordinate appropriate testing • Maintain controlled validation records, specifications, test scripts, and other lifecycle documentation • Work with laboratory scientists, QA, IT, developers, project managers, and business stakeholders to translate laboratory requirements into validated solutions • Lead implementation and validation activities, review other analysts' work, resolve complex issues, provide subject-matter expertise, and support audits/inspections • Provide technical expertise to LIMS products and computer system validation

🎯 Requirements

• Advanced Degree plus 4+ years of experience, or bachelor's degree plus 5+ years of LIMS experience • Experience with Thermo Fisher SampleManager and/or Watson LIMS platform • Experience in pharma, biotech, CRO, or regulated laboratory environments • Demonstrated experience supporting system implementations and validations • Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 • Hands-on experience authoring and executing IQ/OQ/PQ and related validation documentation • Experience working directly with clients in a consulting, vendor, or services capacity • Strong understanding of SDLC and system implementation methodologies • Excellent communication skills with the ability to manage client expectations and present clearly • Strong client-facing and consulting skills • Ability to translate technical and regulatory concepts into practical solutions • Project ownership and accountability for deliverables • Problem-solving in fast-paced implementation environments • Collaboration across cross-functional delivery teams • Detail-oriented with a strong compliance mindset • Familiarity with Agile or hybrid delivery models • Experience with validation tools, test management systems, or ITSM platforms • Prior experience in a professional services or consulting organization • Ability to manage multiple priorities in a project-driven environment • Ability to travel