Senior CSV Validation Engineer - Remote, GxP Compliance

Jobgether; Österreich; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Remote-friendly

Autonomy

Professional growth

Zusammenfassung

Jobgether is representing a partner company in Austria seeking a CSV Validation Engineer with senior, hands-on experience. The role focuses on risk-based validation across cloud, edge, APIs, and instrumentized systems to ensure FDA/EU compliance and inspection-ready evidence.

You will collaborate across Engineering, Product, Quality, Operations, and suppliers to mature validation practices and maintain validated state throughout system lifecycles.

Qualifikationen

• 10+ years of computerized system validation experience within pharmaceutical, biotechnology, life sciences, or another GxP-regulated environment.

Aufgaben

• Develop and execute risk-based validation strategies for new systems, product features, integrations, infrastructure changes, releases, and customer implementations, defining appropriate scope according to intended use, system complexity, data-integrity risks, and regulatory requirements.

Kenntnisse

Risk-based validation

End-to-end CSV ownership

Technical writing

Analytical thinking

Communication skills

Collaboration across teams

Agile software validation

Tools

LIMS

MES

ELN

QMS

REST APIs

SQL

Jobbeschreibung

Jobgether is representing a partner company in Austria seeking a CSV Validation Engineer with senior, hands-on experience. The role focuses on risk-based validation across cloud, edge, APIs, and instrumentized systems to ensure FDA/EU compliance and inspection-ready evidence.

You will collaborate across Engineering, Product, Quality, Operations, and suppliers to mature validation practices and maintain validated state throughout system lifecycles.