Validation Specialist (remote US)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale.

Join the PPD clinical research business of Thermo Fisher Scientific where our mission is to enable our customers to make the world healthier cleaner and safer. We partner with leading pharmaceutical biotechnology medical device academic and government organizations to accelerate the development of life-changing therapies.

As part of our Global Digital & Technology organization youll help ensure the quality and compliance of technology solutions that support clinical research worldwide. Your work directly contributes to patient safety regulatory compliance and the successful delivery of innovative medicines.

Discover Impactful Work
As a Validation Specialist (known internally as a Data Validation Analyst III) you will lead validation activities for regulated computer systems supporting clinical research. You will partner with cross-functional teams to ensure software applications and digital products meet business needs regulatory requirements data integrity expectations and quality standards throughout the system development lifecycle (SDLC).

You will independently support new system implementations enhancements upgrades integrations migrations and ongoing lifecycle activities while applying risk-based validation and Computer Software Assurance (CSA) principles.

A Day in the Life

• Lead computerized system validation (CSV) activities for regulated applications throughout the SDLC.
• Develop review and approve validation deliverables including validation plans risk assessments test strategies/scripts traceability matrices deviations and validation summary reports.
• Partner with Quality Assurance IT Business Analysts system owners vendors and project teams to ensure systems meet business quality and regulatory requirements.
• Review requirements specifications configurations vendor documentation and change controls to ensure they are clear testable traceable and validation ready.
• Define and oversee risk-based testing strategies and ensure validation evidence is complete accurate traceable and inspection-ready.
• Assess system changes and determine appropriate validation scope based on risk intended use and regulatory requirements.
• Investigate validation deviations test failures and system-related quality issues including assessment of compliance and data integrity impact.
• Support internal sponsor and regulatory audits and inspections as a validation subject matter expert.
• Provide technical guidance and peer review to validation and project team members.
• Contribute to continuous improvement of validation procedures templates standards and governance practices.

This is a home-based role for qualified candidates in the US. Band 6.

Applications accepted through 9/8/26.

Keys to Success

Qualifications

• Bachelors degree in computer science Information Systems Life Sciences Engineering Quality or a related discipline
• Experience
• 5 years of progressive experience in computerized system validation computer software assurance software quality or validation within a regulated environment.
• Demonstrated experience independently leading complex validation activities and providing technical direction to cross-functional teams.
• Experience supporting GxP-regulated systems preferably within pharmaceutical biotechnology CRO medical device laboratory or healthcare environments.
• Experience working within Agile Waterfall or hybrid SDLC methodologies.
• Experience with risk assessments change control deviation management requirements traceability testing and maintenance of validated systems.

Preferred Qualifications

Experience with:

• Enterprise applications SaaS/cloud solutions COTS software integrations or data migrations preferred.
• Jira Azure DevOps HP ALM electronic validation lifecycle management systems or similar validation/testing tools.
• Supporting clinical trial systems such as CTMS eTMF EDC Safety LIMS ERP laboratory and other GxP-regulated systems.
• Participating as a validation subject matter expert in regulatory inspections customer audits or sponsor audits.
• Supplier assessments and leveraging vendor documentation within a risk-based validation strategy.
• Supporting system integrations interfaces data migrations or complex application environments.
• Familiarity with Computer Software Assurance (CSA) concepts and modern risk-based assurance approaches.
• Developing or improving validation procedures templates standards or governance practices.

Knowledge Skills & Abilities

• Strong knowledge of CSV principles and computerized system lifecycle management.
• Strong knowledge of FDA 21 CFR Part 11 GAMP 5 GxP ALCOA data integrity and risk-based validation methodologies.
• Familiarity with CSA principles and contemporary risk-based assurance approaches.
• Strong analytical problem-solving documentation and technical writing skills.
• Ability to critically review validation and technical documentation and identify compliance quality and data integrity risks.
• Strong communication and stakeholder management skills with the ability to influence technical and non-technical teams.
• Ability to manage multiple complex projects and priorities with limited supervision.
• Ability to provide technical leadership guidance peer review and coaching.
• Proficiency with Microsoft Office; experience with Jira Azure DevOps HP ALM or similar validation/testing tools preferred.
• Experience with clinical/GxP systems such as CTMS eTMF EDC Safety LIMS ERP or laboratory systems preferred.

At Thermo Fisher Scientific we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position which also includes the possibility of equivalent experience:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require as-needed travel (0-20%).

Location: Remote US. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check which includes a drug screening.

The annual salary range estimated for this position in North Carolina is $80000- $115000 USD. This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy.