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CSV Engineer

  1. Dublin
  1. Contract
Competitive
25047/AN
  1. CAPEX Projects
Date Posted08 Jul 2020

This vacancy has now expired

Contract opportunity for a senior CSV consultant to join an established pharmaceutical company just outside the capital city of Ireland.

This role is ideal for someone who likes a challenge and enjoys having a wide scope of responsibilities!

Responsibilities include but are not limited to:
  • Generating, co-ordinating and executing Commissioning and Qualification CSV protocols for configurable (GAMP Category 4) applications to category 5 PLC controlled equipment in an FDA regulated environment (compliant 21 CFR Parts 11, 210,/211, EU Annex 11 and GAMP 5)
  • Performing gap analysis, determining 21 Part 11 / Annex 11 compliance and carrying out Vendor Evaluations, GXP Assessments and 21 CFR Part 11 Assessments on GxP systems
  • Responsible for generating and maintaining the Computer System Validation Master Plan and all associated systems life-cycle documentation in accordance with Mallinckrodt Pharmaceuticals site procedures and templates.
  • Witnessing of Control System (BMS/PCS) Software FAT and coordination of FAT report review and approval.
  • Responsible for reviewing and approving software Change Management activities during the project lifecycle while considering impact of changes to Manufacturing and Facilities equipment.  
 The client is looking for someone with 7 Years+ experience within Computer System Validation. Previous experience writing and executing CSV test scripts and experience being involved with FDA audits/ inspections all within a Biotech environment.


If you think you have the right experience for this job please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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