Global CSV Specialist — GxP Validation & Compliance

Roquette

Newark (DE)

Vor Ort

USD 91.000 - 121.000

Vollzeit

Vor 7 Tagen

Sei unter den ersten Bewerbenden

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Benefits dieser Stelle

Career growth

Performance bonus

Comprehensive benefits

Retirement contribution

Paid time off

Company holidays

Maternity/Parental leave

Student loan assistance

Tuition reimbursement

Wellness program

Zusammenfassung

Roquette, a family-owned global leader in plant-based ingredients, seeks a Computerized System Validation Specialist to safeguard patient safety, product quality, and data integrity across GxP systems. You will own the risk-based CSV framework and ensure compliance across projects and sites.

You will support audits, maintain the Validation Master Plan, and partner with Quality, Digital/IT, and Operations to advance scalable, Agile-friendly validation practices for ERP, LIMS, CDS, and cloud

Qualifikationen

Master's degree in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or a related discipline.
3-5 years' experience in CSV, Quality Assurance, Digital Quality, or related regulated GxP environments.
Experience with validation lifecycle deliverables and oversight.

Aufgaben

Own and apply risk-based CSV framework for GxP applications, platforms, and digital solutions across Roquette.
Ensure compliance with EU GMP Annex 11/15, FDA 21 CFR Part 11, GAMP 5, data integrity, and internal procedures.
Embed quality requirements from project initiation through implementation, operation, and retirement.

Kenntnisse

GxP compliance

Regulatory knowledge

Audits

Cross-functional collaboration

Ausbildung

Master's degree (Bac+5) in Life Sciences/Pharmacy/Engineering/CS/Quality

Tools

LIMS

CDS

eQMS

Jobbeschreibung

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