Computerized System Validation Engineer

5 dagen geleden


Tilburg, Noord-Brabant, Nederland Oxford Global Resources Voltijd

Job Description

Oxford Global Resources is seeking a highly skilled Computerized System Validation Engineer to join our team in Tilburg. As a CSV Engineer, you will play a crucial role in cultivating the transition to digitalize and automate our production processes and quality control initiatives.

Key Responsibilities

  • Execute and/or lead GxP CSV projects in accordance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15;
  • Ensure GxP systems meet manufactured use and required specifications;
  • Monitor current industry practices and company policies and procedures;
  • Maintain knowledge of cGMP automation/computer systems validation within an EMA/FDA regulated environment.

Requirements

  • A bachelor's or university degree in a relevant field (e.g., IT, Science, or related field);
  • Ability to thrive in a matrix organization, managing interfaces between functional and project organizations;
  • Effective project management and prioritization skills, with excellent written and practical communication skills;
  • Good handling of time-sensitive and safe situations with proper risk assessment;
  • Ability to learn and work according to the latest industry standards and designated computer validation practices;
  • Solid background in one or more areas involved, such as validation, GMP, pharmaceutical production, and IT.

Benefits

  • Employment contract through Oxford Global Resources;
  • Salary indication €4500 - €5500 gross per month based on experience;
  • Working hours: 40 hours per week in day shift;
  • Region: Tilburg;
  • Vacaturenummer: 24235.


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