CSV Specialist

Responsibilities • Lead and manage computer system validation (CSV) projects, including authoring and executing specifications and validation documentation for enterprise systems. • Develop and author validation protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies. • Perform reviews and remote execution of validation protocols in accordance with cGMP, ISPE GAMP 5, and corporate standards. • Ensure data integrity, system security, access control, and user safety are adequately addressed within validation documentation. • Conduct risk assessments and prepare validation summary reports aligned with GMP and regulatory requirements. • Investigate and support resolution of Deviations, CAPAs, and other quality system activities, including Periodic Reviews. • Create comprehensive validation deliverables, including plans, specifications, protocols, traceability matrices, and change controls. • Validate software for manufacturing instruments while managing up to four concurrent validation projects. • Waters/Empower/OSI PI/MODA/Unicorn/Process Pad or products serving the same function. • Various Manufacturing Instruments Software. • Other Enterprise Applications as Required. Requirements: • 7+ years of experience in FDA-regulated industries with strong knowledge of GMP, 21 CFR Part 11, and Annex 11. • 5+ years of experience in document authoring, SOP revisions, and protocol re-execution. • Demonstrated ability to manage multiple concurrent validation or system implementation projects. • Experience validating software for manufacturing instruments, as well as enterprise systems such as SAP, Empower, and Veeva or similar. • Proficient in both traditional (V-Model) and modern (CSA) validation approaches. • Familiarity with Agile and Waterfall methodologies in system and software development environments. • Excellent written and verbal communication skills; strong collaborator with cross-functional teams. • Self-motivated, adaptable, and customer-focused, with a proactive approach to leadership and problem-solving. • BS/BA required in a related field. • 5+ years minimum required relevant experience.