Wood

Computer Systems Validation Engineer

Wood

contract

Posted on:

Origin:  • 🇬🇧 United Kingdom

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Job Level

Mid-LevelSenior

Tech Stack

SwitchingUnix

About the role

  • Work with end business users on development of user requirements and specifications.
  • Approve technical design documentation supplied by vendors such as hardware/Software/Functional Design Specifications.
  • Identify and mitigate system risks through Client’s Technical Risk Assessment process.
  • Plan, develop and execute validation documentation including validation master plans, FAT/SAT documents, commissioning protocols, risk assessments, and summary reports for major equipment and HVAC systems.
  • Develop and improve procedures, practices, and policies related to computer system validation and maintain the Validation Master Plan.
  • Participate and set maintenance life plans for computer systems associated with major equipment and HVAC systems.
  • Utilise electronic validation systems (KNEAT) to complete validation activities.
  • Act as a validation SME across site projects and collaborate with business process owners, technical system owners, and QA validation.

Requirements

  • Bachelor of Science or Arts or equivalent experience
  • Pharmaceutical Manufacturing and Computerised Systems and Validation
  • Experience with ISPE GAMP Computer System Development Life cycle methodology.
  • Knowledge of Client Server environment, UNIX, NT, Windows, Data communications equipment (Routers, Switches, LAN/WAN, PLC).
  • Experience with Quality systems like Change control, CAPA, and deviations.
  • Experience using electronic validation systems (KNEAT)