Senior LIMS Validation Lead — Remote (Watson/LIMS)

Regulatory Jobs; Pennsylvania; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific seeks a Senior Validation Specialist to provide expert LIMS validation across US projects. You will implement, validate, and support LIMS systems with emphasis on GxP compliance and data integrity. Remote work supports frequent client interaction and cross-functional collaboration.

You will lead validation activities, author IQ/OQ/PQ documents, and coordinate testing with scientists, QA, IT, and project teams, ensuring timely delivery and audit readiness.

Qualifications

• Advanced degree plus 4+ years of LIMS experience or a 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 lab environments.
• Knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5.
• Hands-on IQ/OQ/PQ validation documentation experience.
• Experience working with clients in a consulting, vendor, or services capacity.
• Strong SDLC understanding and cross-functional collaboration.

Responsibilities

• LIMS support: implement, configure, maintain, troubleshoot, and support LIMS products.
• CSV: develop and execute validation docs including requirements, risk assessments, test scripts, and traceability.
• Testing: perform functional, regression, integration, and user-acceptance testing with results.
• Compliance: ensure systems meet GxP/GLP data-integrity requirements.
• Change control: assess changes for validation impact and coordinate testing.
• Documentation: maintain validation records, specs, test scripts, lifecycle docs.
• Business/user support: translate lab requirements into validated solutions with stakeholders.
• Senior-level: lead validation activities, review others' work, support audits/inspections.

Skills

Watson knowledge

Client-facing

Consulting skills

SDLC knowledge

Regulatory compliance

Agile/hybrid delivery

Travel willingness

Education

Advanced degree in a relevant field

Bachelor's degree in a relevant field

Job description

Thermo Fisher Scientific seeks a Senior Validation Specialist to provide expert LIMS validation across US projects. You will implement, validate, and support LIMS systems with emphasis on GxP compliance and data integrity. Remote work supports frequent client interaction and cross-functional collaboration.

You will lead validation activities, author IQ/OQ/PQ documents, and coordinate testing with scientists, QA, IT, and project teams, ensuring timely delivery and audit readiness.