CSV & Data Integrity Lead (GxP)

Roquette; Wilmington (DE); On-site; USD 91,000 - 121,000; Full time

Benefits offered by this job

Competitive pay

Annual performance bonus

Retirement contribution

Paid time off

Parental leave

Tuition reimbursement

Wellness programs

Job summary

Roquette, a family-owned global leader in plant-based ingredients, seeks a Computerized System Validation Specialist to lead risk-based CSV across GxP systems. The role requires ensuring regulatory compliance and data integrity while partnering with Quality and Digital/IT teams.

This office-based position supports multiple sites, offers a competitive compensation package, and opportunities for growth within the Quality Management Systems Team.

Qualifications

• Master’s degree (or equivalent Bac+5) in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or a related discipline.
• Minimum of 3–5 years’ experience in Computerized Systems Validation (CSV) within regulated environments.
• Experience with validation lifecycle deliverables and GxP oversight is strongly preferred.

Responsibilities

• Own and apply the risk-based CSV framework for GxP systems across Roquette Group.
• Ensure compliance with EU GMP Annex 11/15, FDA 21 CFR Part 11, GAMP 5 and data integrity principles.
• Maintain Validation Master Plan, CSV policies, and system inventory; support audits and inspections.
• Partner with Quality, business and Digital/IT to integrate compliance by design into projects.

Skills

CSV risk-based validation

GxP compliance awareness

Quality Management Systems

Data integrity principles

Education

Master’s degree (Bac+5) in Life Sciences, Pharmacy, Engineering, Computer Science, or related

Tools

URS

Validation Plans

GxP documentation

Job description

Roquette, a family-owned global leader in plant-based ingredients, seeks a Computerized System Validation Specialist to lead risk-based CSV across GxP systems. The role requires ensuring regulatory compliance and data integrity while partnering with Quality and Digital/IT teams.

This office-based position supports multiple sites, offers a competitive compensation package, and opportunities for growth within the Quality Management Systems Team.