CSV Engineer

Job Description

Overview

Would you like the opportunity to be part of a dynamic team committed to continuously improving the Computer System Validation (CSV) Process for groundbreaking Cell Therapy products? As a CSV Engineer, you will be responsible executing the CSV Lifecycle.

Responsibilities

HOW YOU WILL MAKE AN IMPACT

• Responsible for validation of SaaS systems and computerized laboratory equipment.
• Support the continuous improvement of validation documentation and processes.
• Act as the contact person for validation issues, together with the relevant process, validation and system owners, project management and SMEs.
• Assist in investigating and resolving discrepancies/deviations
• Conduct periodic review of software systems for configuration reconciliation, change review, and validation maintenance.
• Conduct ERES Assessments and Data Integrity Assessments.
• Support inspections by regulatory agencies along with internal and external audits.
• Create CSA documents and records according to standard operating procedures.
• Apply experience in handling quality deviations, creating and raising quality issues and preparing CAPAs.

Job Requirements

MINIMUM QUALIFICATIONS

• BS in Computer Science, Engineering, or other Technical Degree with 5 years' experience working in a regulated GMP environment, preferably in a biopharmaceutical or Cell Therapy manufacturing.
• Proficient with MS Word, Excel, PowerPoint, Visio, and other MS Office suite applications.

Preferred Qualifications

• Evidence of teamwork, leadership and innovation is strongly desired.
• Experience with ValGenesis.
• Knowledge in computer system lifecycle activities, CSV / CSA, and IT controls in a regulated environment
• Good understanding of validation principles and practices following a risk-based approach