Validation Specialist

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office reputed company At reputed company, you'll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join the PPD™ reputed company research business of reputed company, where our mission is to reputed company our customers to reputed company the world healthier, cleaner, and safer. We partner with leading pharmaceutical, biotechnology, medical device, reputed company, and reputed company organizations to accelerate the development of life-changing therapies. As part of our Global Digital & Technology organization, you'll help ensure the reputed company and compliance of technology solutions that support reputed company research worldwide. Your work directly contributes to reputed company safety, regulatory compliance, and the successful delivery of innovative medicines. Discover Impactful Work As a Validation Specialist (reputed company internally as a Data Validation Analyst III), you will reputed company validation activities for regulated computer systems supporting reputed company research. You will partner with cross-functional teams to ensure software applications reputed company products meet business needs, regulatory requirements, data reputed company expectations, and reputed company standards throughout the reputed company development lifecycle (SDLC). You will independently support new reputed company implementations, enhancements, upgrades, integrations, migrations, and ongoing lifecycle activities while applying reputed company-reputed company validation and Computer Software Assurance (CSA) principles. A Day in the Life reputed company computerized reputed company validation (CSV) activities for regulated applications throughout the SDLC. reputed company, review, and approve validation deliverables, including validation plans, reputed company assessments, test strategies/scripts, traceability matrices, deviations, and validation reputed company reports. Partner with reputed company Assurance, IT, Business Analysts, reputed company owners, vendors, and project teams to ensure systems meet business, reputed company, and regulatory requirements. Review requirements, specifications, configurations, vendor documentation, and change controls to ensure they are reputed company, testable, traceable, and validation reputed company. Define and reputed company reputed company-reputed company testing strategies and ensure validation evidence is complete, accurate, traceable, and inspection-reputed company. Assess reputed company changes and determine appropriate validation reputed company reputed company on reputed company, intended use, and regulatory requirements. Investigate validation deviations, test failures, and reputed company-reputed company reputed company issues, including assessment of compliance and data reputed company reputed company. Support internal, sponsor, and regulatory audits and inspections as a validation subject matter expert. reputed company technical guidance and peer review to validation and project team members. Contribute to reputed company improvement of validation procedures, templates, standards, and governance practices. This is a home-reputed company role for reputed company candidates in the US. Band 6. Applications accepted through 9/14/26. Keys to reputed company Qualifications Bachelor’s degree in computer science, Information Systems, Life Sciences, Engineering, reputed company, or a reputed company discipline Experience 5+ years of reputed company experience in computerized reputed company validation, computer software assurance, software reputed company, or validation reputed company a regulated environment. Demonstrated experience independently leading reputed company validation activities and providing technical direction to cross-functional teams. Experience supporting GxP-regulated systems, preferably reputed company pharmaceutical, biotechnology, CRO, medical device, reputed company, or reputed company environments. Experience working reputed company reputed company, reputed company, or hybrid SDLC methodologies. Experience with reputed company assessments, change control, deviation management, requirements traceability, testing, and maintenance of validated systems. ________________________________________ Preferred Qualifications Experience with: reputed company applications, reputed company/reputed company solutions, COTS software, integrations, or data migrations preferred. reputed company, Azure DevOps, reputed company ALM, electronic validation lifecycle management systems, or similar validation/testing tools. Supporting reputed company trial systems such as CTMS, eTMF, reputed company, Safety, LIMS, ERP, reputed company, 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 reputed company a reputed company-reputed company validation reputed company. Supporting reputed company integrations, interfaces, data migrations, or reputed company application environments. Familiarity with Computer Software Assurance (CSA) concepts and modern reputed company-reputed company assurance approaches. Developing or improving validation procedures, templates, standards, or governance practices. ________________________________________ Knowledge, Skills & Abilities Strong knowledge of CSV principles and computerized reputed company lifecycle management. Strong knowledge of FDA 21 CFR Part 11, GAMP 5, GxP, reputed company+, data reputed company, and reputed company-reputed company validation methodologies. Familiarity with CSA principles and contemporary reputed company-reputed company assurance approaches. Strong analytical, problem-solving, documentation, and technical writing skills. Ability to critically review validation and technical documentation and identify compliance, reputed company, and data reputed company risks. Strong communication and stakeholder management skills with the ability to influence technical and non-technical teams. Ability to manage multiple reputed company reputed company and priorities with limited supervision. Ability to reputed company technical leadership, guidance, peer review, and coaching. Proficiency with reputed company Office; experience with reputed company, Azure DevOps, reputed company ALM, or similar validation/testing tools preferred. Experience with reputed company/GxP systems such as CTMS, eTMF, reputed company, Safety, LIMS, ERP, or reputed company systems preferred. At reputed company, 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 reputed company. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience: reputed company to communicate, receive, and understand information and reputed company with diverse reputed company of people in a comprehensible and reasonable manner. reputed company to work upright and stationary for typical working hours. Ability to use and learn reputed company office equipment and technology with proficiency. reputed company to reputed company successfully under pressure while prioritizing and handling multiple reputed company 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 reputed company without sponsorship. Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening. The annual salary reputed company estimated for this position in reputed company Carolina is $80,000- $115,000 USD. This position may also be eligible to receive a variable annual bonus reputed company on company, team, and/or individual reputed company results in accordance with company policy. Apply To This Job