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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

CSV Engineer

TSP
Hopkinton, MA
Full Time

Published on 01/23/2023

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