Lead CSV Engineer: GMP Validation & Compliance Leader

QvalFocus Inc.; New Jersey; On-site; USD 140,000 - 210,000; Full time

Job summary

QvalFocus Inc. in New Jersey seeks a Lead CSV Engineer to lead Computer System Validation for capital and strategic projects in a GMP-regulated setting. You will guide CSV/CSA practices, review validation deliverables, and ensure systems meet regulatory requirements.

The role requires deep knowledge of SDLC, risk-based validation, and automation compliance. You will collaborate with Quality, Engineering, Automation, and Project Delivery teams across multiple sites to ensure on-time delivery.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or related field.
• 7+ years of CSV experience in GMP-regulated environments.
• Strong knowledge of CSV, CSA, SDLC and validation compliance for manufacturing, QA, and enterprise systems.
• Familiarity with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GMP requirements.
• Experience authoring, reviewing, and approving validation docs (requirements, risk assessments, test protocols, summaries).
• Knowledge of risk-based validation, system qualification, and lifecycle management.
• Experience supporting capital projects, system implementations, upgrades, and validation activities.
• Familiarity with change control, deviation management, and quality processes.

Responsibilities

• Lead CSV compliance activities for capital projects across multiple sites.
• Develop, review, and approve CSV lifecycle documentation (QAPs, risk assessments, requirements, test protocols, summary reports).
• Provide technical guidance on SDLC, CSA, risk-based validation, and computerized system compliance.
• Review SDLC documentation as technical representative; ensure regulatory alignment.
• Support validation planning, execution, and compliance for GMP systems in manufacturing, labs, quality, and enterprise ops.
• Collaborate with project teams to assess changes, risks, and support change controls and deviations.
• Participate in governance, technical reviews and meetings to address validation requirements.
• Maintain CSV trackers, compliance metrics, validation schedules, and status reports.
• Identify compliance gaps and risks and communicate to Global CSV Compliance Lead.
• Support development and improvement of CSV procedures, SOPs, and practices.
• Coordinate with Quality, IT, Engineering, Automation, and project stakeholders to complete activities on schedule.

Skills

CSV, CSA, SDLC

GAMP 5, FDA 21 CFR Part 11

Regulatory compliance

Independent multi-project oversight

Documentation & communication

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Job description

QvalFocus Inc. in New Jersey seeks a Lead CSV Engineer to lead Computer System Validation for capital and strategic projects in a GMP-regulated setting. You will guide CSV/CSA practices, review validation deliverables, and ensure systems meet regulatory requirements.

The role requires deep knowledge of SDLC, risk-based validation, and automation compliance. You will collaborate with Quality, Engineering, Automation, and Project Delivery teams across multiple sites to ensure on-time delivery.