Senior Validation Specialist, LIMS

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

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

• Develop and execute documentation for computer system validation, which includes requirements, risk assessments, test protocols/scripts, traceability matrices, validation reports, and relevant evidence.

• Conduct functional, regression, integration, and user-acceptance testing.

• Document testing outcomes and analyze test failures and deviations.

• Ensure that systems and documentation comply with applicable GxP/GLP standards and data integrity requirements.

• Evaluate system changes, enhancements, upgrades, and defects for validation impact and coordinate necessary testing.

• Maintain controlled validation records, specifications, test scripts, and other lifecycle documentation.

• Collaborate with laboratory scientists, QA, IT, developers, project managers, and business stakeholders to convert laboratory requirements into validated solutions.

• Lead implementation and validation efforts, review the work of other analysts, resolve complex issues, provide subject-matter expertise, and support audits/inspections.

• Offer technical expertise related to LIMS products and computer system validation.

⛳️ Requirements

• Advanced degree with 4+ years of experience, or a bachelor's degree with 5+ years of LIMS experience.

• Proficiency with Thermo Fisher SampleManager and/or Watson LIMS platform.

• Experience in pharmaceutical, biotech, CRO, or regulated laboratory settings.

• Proven experience in supporting system implementations and validations.

• Strong understanding of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5.

• Practical experience in authoring and executing IQ/OQ/PQ and related validation documentation.

• Experience working directly with clients in a consulting, vendor, or services role.

• Thorough understanding of SDLC and system implementation methodologies.

• Excellent communication skills, with the ability to manage client expectations and present information clearly.

• Strong client-facing and consulting capabilities.

• Ability to translate technical and regulatory concepts into actionable solutions.

• Demonstrated project ownership and accountability for deliverables.

• Effective problem-solving in fast-paced implementation environments.

• Ability to collaborate across cross-functional delivery teams.

• Detail-oriented with a strong compliance-focused mindset.

• Familiarity with Agile or hybrid delivery models.

• Experience with validation tools, test management systems, or ITSM platforms.

• Previous experience in a professional services or consulting organization.

• Capability to manage multiple priorities in a project-driven environment.

• Willingness to travel.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.