Senior Validation Specialist, LIMS

Thermo Fisher Scientific

. Implement, configure, maintain, troubleshoot, and support Thermo Scientific LIMS products .

Posted 9/15/2026full-timeRemote • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in implementing and validating Thermo Scientific LIMS products, ensuring compliance with GxP regulations and data integrity standards. Proficient in developing validation documentation and executing testing protocols while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Thermo Fisher SampleManager ExperienceGxP Regulations KnowledgeValidation Documentation AuthoringClient-Facing Consulting SkillsSDLC Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

LIMS ImplementationComputer System ValidationTest Protocol DevelopmentFunctional TestingRegression TestingIntegration TestingUser-Acceptance TestingRisk AssessmentTraceability MatricesValidation Reports

Soft Skills

Excellent Communication SkillsProblem-SolvingCollaborationDetail-OrientedProject Ownership

Tools & Technologies

Validation ToolsTest Management SystemsITSM PlatformsAgile MethodologiesHybrid Delivery Models

Industry Keywords

PharmaBiotechCRORegulated Laboratory Environments21 CFR Part 11Annex 11GAMP 5

Tech Stack

Tools & technologies

ITSMSDLC

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Thermo Fisher Scientific Website LinkedIn All 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. Senior Validation Specialist, LIMS 🔥 48 minutes ago 🔔 Pennsylvania – Remote ⏰ Full Time 🟠 Senior 🦅 H1B Visa Sponsor 👻 Ghost score 10% Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 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
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