Data Integrity CSV Specialist – GMP QC Systems

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Accessible location in Schaffhausen

Collaborative, inclusive work env.

Work-life balance emphasis

Zusammenfassung

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, is seeking a Specialist - Data Integrity / CSV (80-100%). You will own laboratory computerized systems and analytical software used in GMP operations, ensuring compliance and reliability across the lifecycle.

You will work with Quality Control, Quality Assurance, IT, vendors, and users to qualify, validate, document, and maintain systems. Fluency in English and German is a plus; GMP CSV experience is preferred.

Qualifikationen

• Ph.D., Master’s degree or equivalent in a relevant field.
• Experience in GMP labs, CSV or data integrity environments.
• Windows administration and analytical software administration is a plus.
• Knowledge of ICH Q9 and data governance principles.
• Strong cross‑functional project coordination experience.

Aufgaben

• Manage lifecycle of laboratory computerized systems and analytical software.
• Coordinate qualification, validation, and lifecycle activities with stakeholders.
• Create and maintain SOPs and work instructions.
• Provide IT support for GMP laboratory operations and incidents.

Kenntnisse

Data integrity

Quality control

Analytical skills

Communication skills

English proficiency

German language

IT knowledge

Ausbildung

PhD / Master’s in natural sciences or related field

GMP CSV or data integrity experience

Tools

Windows administration

Microsoft Office

Analytical software administration

Jobbeschreibung

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, is seeking a Specialist - Data Integrity / CSV (80-100%). You will own laboratory computerized systems and analytical software used in GMP operations, ensuring compliance and reliability across the lifecycle.

You will work with Quality Control, Quality Assurance, IT, vendors, and users to qualify, validate, document, and maintain systems. Fluency in English and German is a plus; GMP CSV experience is preferred.