CSV Engineer

30 Sep 2017
03 Nov 2017
Contract Type
Full Time
We are currently recruiting for an experienced Computer Systems Validation Engineer (CSV) to work for one of the world’s leading and most-trusted suppliers to Pharmaceutical, biotech and speciality ingredients market. You will be working within the validation team on permanent basis the role is based in Berkshire.

As a CSV Engineer, you will be responsible for the generation and execution of computer system validation protocols and reports in line with cGMP best practice. You will plan your own work and work as part of validation and wider team supporting GMP manufacturing and supporting functions.

  • Responsible for the generation and execution of validation project plans, protocols and reports.
  • Planning and managing delivery of validation projects and procedures to meet current GMP regulations and guidelines, industry best practice and company policy.
  • Formal review of validation protocols, reports and procedures generated by Lonza staff or external vendors.
  • Process and manage quality records including change control, deviation and CAPA
  • Plan all work with and report progress to the validation scheduler, line manager and internal customer to ensure validation activities are aligned.

Key Skills:
  • 5 Years’ experience
  • Experience delivering CSV projects within the biopharmaceutical industry
  • Good knowledge of GAMP
  • Good working knowledge of Annexe 11 and 21CFR part 11
  • Good knowledge of laboratory computer systems
  • Experience working with hardware and software in a GMP environment
  • Experience of Pharmaceutical Quality Systems including change control, deviation, CAPAs
If this is you please apply today.
This job was originally posted as www.totaljobs.com/job/75966657