Global CSV Specialist for GxP Systems & Data Integrity

Roquette

Town of Newark (WI)

On-site

USD 91,000 - 121,000

Full time

3 days ago

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Benefits offered by this job

Competitive pay

Annual bonus

Retirement contribution

Paid time off

Holidays

Tuition reimbursement

Wellness program

Job summary

Roquette, a family-owned global leader in plant-based ingredients, seeks a Computerized System Validation Specialist within the Quality Management Systems Team. You will own and apply the risk-based CSV framework for GxP applications, platforms, and digital solutions across Roquette, ensuring compliance with EU GMP Annex 11/15 and FDA 21 CFR Part 11.

This role partners with Quality, business and Digital/IT teams to embed compliance from project initiation through operation and retirement,

Qualifications

Education: Master’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, Quality, or related.
3–5 years' CSV/Quality Assurance experience in regulated environments.
Experience with validation of laboratory systems (LIMS, CDS) and related audits.
Knowledge of EU GMP Annex 11/15, FDA 21 CFR Part 11 and GAMP 5 preferred.
Experience supporting audits/regulatory inspections is a plus.

Responsibilities

Own and apply the risk-based CSV framework for GxP apps, platforms, infrastructure and digital solutions.
Ensure compliance with pharmaceutical requirements and industry guidance.
Embed quality requirements from project initiation through retirement.
Maintain regulatory watch and translate into practical standards and controls.
Promote scalable, risk-based validation in Agile, SaaS, and cloud environments.