CSV Engineer

PM Group
UK
about 1 month ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Working hours
Regular working hours
Job source

Tech stack

Application Programming Interfaces (APIs) GXP

Job description

PM Group now wish to recruit a Senior CSV Engineer to join a highly skilled PM Group team based a client site.

The following is an example of the day to day activities:.

  • Commissioning and Qualification of hardware and associated software to support Utility/Process equipment.
  • Documentation preparation of Commissioning, Qualification and Verification protocols (CQV) for process equipment CSV.
  • Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for process equipment automation, including Clean & black utilities.
  • Co-ordination/review of Vendor Automation packages to achieve streamlined CSV
  • People management

Requirements

  • Intermediate to senior (5+ years) CSV (full lifecycle) experience.
  • CSV experience of process equipment manufacturing API
  • Strong knowledge of regulations (GAMP 5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices
  • Experience of working with software/automation validation in a project environment.
  • A degree level in Engineering, or Science related area

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