CSV Engineer

Role: CSV Engineer

Location: New Jersey

Duration: Long Term

Job Description

Our client is seeking an experienced CSV (Computer System Validation) Engineer to replace their current CSV Lead, who is transitioning to another department. The site is in the midst of implementing and validating multiple applications and instruments, and currently lacks a dedicated CSV owner. The chosen candidate will be responsible for validating software across a range of applications, including LIMS, Empower, and various Manufacturing Applications, as well as embedded software on lab instrumentation.

Responsibilities

• Lead CSV efforts for the implementation and validation of site-wide, enterprise-level applications.
• Develop and manage risk assessments and Trace Matrices.
• Create and execute test protocols in compliance with the client’s Quality System.
• Support infrastructure qualification activities.
• Ensure adherence to Data Integrity principles and GAMP5 standards.
• Manage change controls throughout the validation process.
  
  

Qualifications

• Extensive experience in Computer System Validation, including software for applications and embedded lab instrumentation.
• Strong knowledge of Data Integrity principles and GAMP5.
• Proven ability to work within a client’s Quality System.
• Experience in developing risk assessments, Trace Matrices, and test protocols.
• Familiarity with infrastructure qualification processes.
• Effective management of change controls within the validation lifecycle.