Thermofisher·4 days ago
4 days ago
Sr Validation Specialist (LIMS)
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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 , 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 they're looking for
- 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
Nice to have
- Knowledge of Watson, Immune Response Module, Integration Manager and Sample Manager preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Join our team at Thermo Fisher Scientific as a Sr. Validation Specialist, where you'll 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 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
Company
Thermofisher
Remote, Pennsylvania, USA
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