Lead​/Sr Computer System Validation Engineer

Overview

Lead/Sr Computer System Validation Engineer role at Katalyst CRO.

• The CSV Lead manages quality control checks on engineering project work.
• The CSV Lead has 10+ years of experience in automation systems computer systems validation in a GMP environment.
• Assist Client in designing the validation strategy for the overall project and coordinate production of the required CSV protocols.
• Provide leadership to CSV team members in reviewing CSV protocols for various streams and ensuring execution in accordance with Client policy and the Project Plan.
• Liaise with Client Quality to ensure customer quality expectations are met with respect to CSV and provide guidance to the Client.
• Systems include Delta
  
  V, Historian, MES, ABB and other DCS and OT systems.

• Project master validation planning.
• Setting of project CSV guidelines.
• Setting of GDP, cGMP & GAMP project guidelines.
• Quality review of project documentation and testing documentation.
• Quality review of validation documentation.
• Attendance at testing stages and daily client site meetings.
• Familiarity with relevant pharmaceutical / Life Sciences industry standards.
• Familiarity with validation of Delta
  
  V, MES, Historian, ABB and other OT systems.
• Typically 11+ years relevant pharmaceutical / Life Sciences industry experience.

Mid-Senior level

Contract

Pharmaceutical Manufacturing