Lead CSV Engineer jobs in United States
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Jobs via Dice · 6 hours ago

Lead CSV Engineer

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level, Lead/Staff

Dice is the leading career destination for tech experts, and they are seeking a Lead CSV Engineer – Project Lead to oversee Computer System Validation activities for GxP-regulated systems. This role involves ensuring compliance with FDA regulations while providing technical and project leadership throughout the validation lifecycle.

Computer Software

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 regulations complianceProject managementStakeholder managementDocumentation skillsCommunication skills

Required

Strong experience in Computer System Validation (CSV) within GxP-regulated environments
Hands-on experience with Electronic Batch Record (EBR) systems
In-depth knowledge of FDA regulations, GAMP 5, and 21 CFR Part 11 compliance
Proven experience leading validation projects and cross-functional teams
Excellent documentation, communication, and stakeholder management skills
Ability to work effectively with internal teams and external vendors

Preferred

Experience in pharmaceutical, biotech, or life sciences industries
Prior experience handling regulatory audits and inspections
Project management experience or certification is an advantage

Company

Jobs via Dice

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