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Ecocareers · 2 weeks ago

Senior CSV Engineer – Project Lead

Foster, CA

Full-time

Onsite

Senior Level

Ecocareers is a company focused on leading Computer System Validation activities. The Senior CSV Engineer – Project Lead is responsible for managing validation processes for GxP-regulated systems, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to deliver projects effectively.

Staffing & Recruiting

Responsibilities

Lead and manage end-to-end CSV activities for GxP-regulated systems, with primary ownership of EBR platforms

Plan, execute, and review validation deliverables including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports

Ensure compliance with FDA, GAMP 5, 21 CFR Part 11, and other global regulatory standards

Provide technical guidance and project leadership across multiple validation projects

Collaborate with Quality, IT, Manufacturing, Automation, and vendors during system implementations and upgrades

Support change management, deviation management, and periodic reviews for validated systems

Ensure validation activities are completed on schedule and within project scope

Drive continuous improvement initiatives to enhance validation processes and system compliance

Act as a key point of contact for audits and regulatory inspections related to CSV

Qualification

Computer System ValidationElectronic Batch RecordFDA regulationsGAMP 521 CFR Part 11Project managementStakeholder managementRegulatory audits experienceLife sciences experienceDocumentation skillsCommunication skillsTeam collaboration