Thermo Fisher Scientific

Sr Validation Specialist (LIMS)

Thermo Fisher Scientific$100K — $120K *
US-AnywhereRemote in Pennsylvania, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Advanced degree and 4+ years or bachelor's plus 5+ years of LIMS experience.
  • Experience with Thermo Fisher SampleManager or Watson LIMS platforms.
  • Background in pharma, biotech, CRO, or regulated lab environments.
  • Strong knowledge of GxP regulations and validation processes.
  • Proven client support experience in a consulting or vendor role.
  • Excellent communication and problem-solving skills.
  • Familiarity with Agile methodologies and validation tools.

Responsibilities

  • Implement, configure, maintain, and troubleshoot Thermo Scientific LIMS products.
  • Develop and execute validation documentation including test protocols and reports.
  • Perform functional, regression, integration, and user-acceptance testing.
  • Ensure compliance with GxP/GLP and data-integrity requirements.
  • Assess system changes for validation impact and coordinate testing.
  • Maintain controlled validation records and lifecycle documentation.
  • Lead validation activities, review work of analysts, and support audits.

Benefits

  • Remote work flexibility with frequent client interactions.
  • Opportunity to lead and influence validation processes.
  • Exposure to various lab environments and projects.
  • Support from a collaborative and cross-functional team.
  • Access to ongoing professional development opportunities.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Senior Validation Specialist



This role is remote and can site anywhere in US

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

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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