Computerized System Validation Specialist

1 week geleden

Tilburg, Noord-Brabant, Nederland Oxford Global Resources Voltijd

Job Description:

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

Responsibilities:

  • Executing and/or leading GxP CSV projects in accordance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15;
  • Ensuring GxP systems meet the manufactured use and required requirements;
  • Monitoring current industry practices and company policies and procedures;
  • Maintaining knowledge of cGMP automation/computer systems validation within an EMA/FDA regulated environment.

Requirements:

  • A bachelor's or university degree in one of the target areas for the position (e.g., IT, Science, or related field);
  • Ability to thrive in a matrix organization, managing the interface between functional organization and project organization;
  • Excellent written and practical communication skills;
  • Good handling in 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 of the areas involved, such as validation, GMP, and pharmaceutical production and IT.

Benefits:

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

Important Note: Visa sponsorship is not possible for this position. Please do not apply if you do not have a working permit to live and work in the Netherlands. Your application will not be processed.

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