CSV Specialist: Regulated Systems Validation & Lifecycle Expert

PerkinElmer; Schweiz; Vor Ort; EUR 107.411 - 150.375; Vollzeit

Zusammenfassung

PerkinElmer seeks a Computerized System Validation Specialist to join the customer-site team in Schachen. The CSV Specialist reviews validated systems documentation to ensure ongoing validated state, considering device lifecycle and norms evolution.

You will participate in decommissioning, CAPA, and change management, collaborating with Lifecycle Excellence, IT and QA, and may author or execute new validation projects.

Qualifikationen

• Strong knowledge of FDA regulations and validation requirements.
• Experience with GDP, GMP, GCP and GLP.
• Experience authoring/reviewing validation documentation.
• Ability to work independently and in cross-functional teams.

Aufgaben

• Review validated systems documentation to ensure ongoing validation.
• Execute decommissioning process and own Decommissioning Check List (DCL).
• Collaborate with Lifecycle Excellence, IT and QA to implement CSV programs.
• Contribute to CAPA, change management and deviation tracking.
• Author or execute new system validation projects with cross-functional teams.

Kenntnisse

English fluency

German language skills

Attention to detail

Cross-functional collaboration

Independent work

Project management

Tools

Kneat eVal

Jobbeschreibung

PerkinElmer seeks a Computerized System Validation Specialist to join the customer-site team in Schachen. The CSV Specialist reviews validated systems documentation to ensure ongoing validated state, considering device lifecycle and norms evolution.

You will participate in decommissioning, CAPA, and change management, collaborating with Lifecycle Excellence, IT and QA, and may author or execute new validation projects.