Sr Validation Specialist (WatsonLIMS)

Work Schedule

Environmental Conditions

Job Description

Senior Validation Specialist

R-

This role is remote and can site anywhere in US

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Join our team at Thermo Fisher Scientific as a Sr. Validation Specialist where youll provide technical expertise to our LIMS products and computer system validation.

• 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 bachelors 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

• Extensive Watson knowledge
• 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