Sr Validation Specialist (Watson/LIMS)

Thermo Fisher Scientific•Pittsburgh, PA

2d•Remote

About The Position

As part of Thermo Fisher Scientific, the Senior Validation Specialist provides technical expertise for LIMS products and computer system validation. The role supports Thermo Scientific LIMS products, including implementation, configuration, maintenance, troubleshooting, and user support. It develops and executes computer system validation documentation and testing, ensuring systems and records meet applicable GxP/GLP and data-integrity requirements. The specialist works with laboratory scientists, QA, IT, developers, project managers, clients, and other business stakeholders to translate laboratory requirements into validated solutions. At the senior level, the role leads implementation and validation activities, reviews other analysts’ work, resolves complex issues, provides subject-matter expertise, and supports audits and inspections. The role is remote and can be based anywhere in the United States. It follows a standard Monday–Friday schedule, with frequent client interaction and possible travel for key project phases.

Requirements

High school diploma or GED and LIMS experience are required.
Experience with Thermo Fisher SampleManager and/or Watson LIMS platforms.
Experience in pharmaceutical, biotechnology, CRO, or other 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, including the ability to manage client expectations and present clearly.
Ability to translate technical and regulatory concepts into practical solutions.
Project ownership and accountability for deliverables.
Problem-solving ability in fast-paced implementation environments.
Ability to collaborate across cross-functional delivery teams.
Detail-oriented approach and strong compliance mindset.
Ability to manage multiple priorities in a project-driven environment.
Ability to travel.

Nice To Haves

Bachelor’s degree or higher.
Five or more years of LIMS experience.
Knowledge of Watson, Immune Response Module, Integration Manager, and Sample Manager.
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.

Responsibilities

Implement, configure, maintain, troubleshoot, and support Thermo Scientific LIMS products.
Develop and execute validation documentation, including requirements, risk assessments, test protocols and scripts, traceability matrices, validation reports, and supporting evidence.
Perform functional, regression, integration, and user-acceptance testing; document 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.
Collaborate with laboratory scientists, QA, IT, developers, project managers, clients, 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 and inspections.
Manage client expectations, communicate clearly, and take ownership of project deliverables.
Travel as needed for key project phases.