Pharma CSV Validation Engineer - Quality & Compliance

Proclinical; Schweiz; Vor Ort; CHF 65.000 - 84.000; Vollzeit

Zusammenfassung

Proclinical is seeking a CSV Engineer to support validation activities in a sterile pharmaceutical manufacturing environment in Ireland. You will ensure regulatory compliance, maintain the validated state of computerized systems, and contribute to continuous improvement initiatives.

Collaborating with Manufacturing, Engineering, and Quality teams, you will design and execute validation studies, review protocols, and support inspections and audits to ensure product quality and patient safety.

Qualifikationen

• Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering.
• Strong CSV principles and lifecycle knowledge.
• Familiarity with cGMP and regulatory requirements.
• Experience in validation or CSV in pharma/healthcare.
• Ability to troubleshoot validation-related issues.

Aufgaben

• Validate new computerized equipment, automation and control systems.
• Generate and review validation documentation (protocols/reports).
• Execute DQ/IQ/OQ/PQ validation activities.
• Support change controls and CSV requirements.
• Design, implement and execute validation studies for manufacturing, utility and control systems.
• Ensure validation activities comply with health, safety, cGMP and regulatory requirements.
• Maintain the validated state of computerized systems through lifecycle management.
• Develop, review, execute and approve validation/revalidation plans.
• Review and approve change controls impacting validated systems.
• Provide technical support on FDA, EU GMP and validation requirements.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality and others.
• Support inspections and audits as required.

Kenntnisse

CSV fundamentals

Lifecycle management

GAMP/ISPE guidance

cGMP knowledge

Validation in pharma

Project management

Cross-functional collaboration

Analytical problem solving

Ausbildung

Science or Engineering degree

Jobbeschreibung

Proclinical is seeking a CSV Engineer to support validation activities in a sterile pharmaceutical manufacturing environment in Ireland. You will ensure regulatory compliance, maintain the validated state of computerized systems, and contribute to continuous improvement initiatives.

Collaborating with Manufacturing, Engineering, and Quality teams, you will design and execute validation studies, review protocols, and support inspections and audits to ensure product quality and patient safety.