Senior CSV Engineer - Project Lead

Piper Companies is hiring a Senior CSV Engineer - Project Lead for a remote contract position with a leading consulting firm supporting pharmaceutical and life sciences clients. The Senior CSV Engineer - Project Lead will lead and execute Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This is a 6-month remote contract position based on EST, with potential for extension.

Responsibilities of the Senior CSV Engineer - Project Lead:

• 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.
• Collaborate with Quality, IT, Manufacturing, Automation, and vendors during system implementations and upgrades.
• Act as a key point of contact for audits and regulatory inspections related to CSV.

Qualifications of the Senior CSV Engineer - Project Lead:

• 9–10 years of 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.

Compensation for the Senior CSV Engineer - Project Lead:

• Salary: $114,000-$124,000/year (USD)
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday, and Sick Leave if Required by Law

This job opens for applications on 12/29/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Computer System Validation, CSV, GxP, EBR, FDA compliance, GAMP 5, 21 CFR Part 11, validation lifecycle, URS, FRS, IQ/OQ/PQ, pharmaceutical, biotech, life sciences, audits, regulatory inspections, project leadership, stakeholder management, continuous improvement, change management, deviation management, risk assessments, validation reports.

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