Global CSV Specialist – GxP Compliance & Validation

Roquette Group; Newark (DE); In loco; USD 91.000 - 121.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive pay

Annual bonus

Retirement contribution 6.2%

Professional development

Paid time off

Company holidays

Parental leave

Student loan assistance

Tuition reimbursement

Wellness programs

Descrizione del lavoro

Roquette is seeking a Computerized System Validation Specialist to join its Quality Management Systems Team. You will safeguard patient safety, product quality, and data integrity by ensuring GxP computerized systems remain compliant throughout their lifecycle.

This role supports regulatory compliance, partners with business and Digital/IT teams to implement risk-based validation across Roquette, and will be based in Newark, DE or Midland, MI.

Competenze

• Master's degree in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or related discipline.
• 3-5 years' experience in Computerized Systems Validation (CSV) within regulated environments.
• Experience with laboratory systems like LIMS, CDS, lab execution systems, or instrument-integrated systems.

Mansioni

• Own and apply the risk-based CSV framework for GxP applications across Roquette Group.
• Ensure compliance with pharmaceutical requirements including EU GMP Annex 11/15, FDA 21 CFR Part 11, GAMP 5, data integrity, and internal procedures.
• Embed quality and compliance requirements from project initiation through retirement.
• Maintain regulatory watch and translate new expectations into practical standards and remediation plans.
• Promote scalable, risk-based validation practices for Agile, SaaS, cloud, and modern digital delivery models.

Conoscenze

Quality Assurance

CSV

Regulatory compliance

Risk assessment

Formazione

Master's degree in Life Sciences or related field

Strumenti

LIMS

CDS

eQMS

ERP

MES

GAMP 5

Descrizione del lavoro

Roquette is seeking a Computerized System Validation Specialist to join its Quality Management Systems Team. You will safeguard patient safety, product quality, and data integrity by ensuring GxP computerized systems remain compliant throughout their lifecycle.

This role supports regulatory compliance, partners with business and Digital/IT teams to implement risk-based validation across Roquette, and will be based in Newark, DE or Midland, MI.