Sr Validation Specialist (Watson/LIMS)

Overview

Provide technical expertise on Thermo Scientific LIMS products and computer system validation, supporting implementation, configuration, testing and compliance of regulated laboratory systems.

What you'll do

• Implement, configure, maintain, troubleshoot and support Thermo Scientific LIMS products.
• Develop and execute validation documentation such as requirements, risk assessments, test protocols/scripts, traceability matrices, validation reports and associated evidence.
• Perform functional, regression, integration and user-acceptance testing; document results and investigate test failures/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.

What you'll need

• HS Diploma or GED required with LIMS experience required.
• 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.
• Ability to manage multiple priorities in a project-driven environment.
• Ability to travel.

Nice to have

• Knowledge of Watson, Immune Response Module, Integration Manager and Sample Manager.
• Bachelor's degree or higher, plus 5+ years of LIMS experience.
• 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.

Details

• Work schedule: standard Monday to Friday.
• Remote role; can be sited anywhere in the US.
• Frequent client interaction.
• Travel may be required for key project phases.