Sr Validation Specialist (LIMS)

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Senior Validation Specialist

R-01364317

This role is remote and can site anywhere in US

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

• LIMS support: Implement, configure, maintain, troubleshoot, and support Thermo Scientific LIMS products. Knowledge of Watson, Immune Response Module, Integration Manager and Sample Manager preferred.
• Computer System Validation (CSV): Develop and execute validation documentation such as requirements, risk assessments, test protocols/scripts, traceability matrices, validation reports, and associated evidence.
• Testing: Perform functional, regression, integration, and user-acceptance testing; document results and investigate test failures/deviations.
• Compliance: Ensure systems and documentation meet applicable GxP/GLP , data-integrity requirements.
• Change control: Assess system changes, enhancements, upgrades, and defects for validation impact and coordinate appropriate testing.
• Documentation: Maintain controlled validation records, specifications, test scripts, and other lifecycle documentation.
• Business/user support: Work with laboratory scientists, QA, IT, developers, project managers, and business stakeholders to translate laboratory requirements into validated solutions.
• Senior-level responsibilities: Lead implementation and validation activities, review other analysts' work, resolve complex issues, provide subject-matter expertise, and support audits/inspections.

Required Qualifications

• 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 

Key Competencies

• 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 

Work Environment

• Remote with frequent client interaction 

• Travel may be required for key project phases