Computerized System Validation Engineer

4 weken geleden

Tilburg, Noord-Brabant, Nederland Oxford Global Resources Voltijd
Job Description

In a rapidly evolving environment where digitalization and automation of production processes and quality control are crucial, we are seeking a skilled Computerized System Validation Engineer to drive this transition for our client in Tilburg. If you thrive in a multidisciplinary, highly technical environment where personal development is a top priority, this role may be an excellent fit.

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 requirements.
  • 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 the interface between functional and project organizations.
  • Effective project management and 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, and pharmaceutical production and IT.
Benefits
  • Employment: year contract through Oxford Global Resources, with intention to extend or take over.
  • Salary indication €4500 - €5500 gross per month based on experience.
  • Working hours: 40 hours per week in day shift.
  • Region: Tilburg.

Please note that visa sponsorship is not possible for this position. Only candidates with a valid working permit for the Netherlands should apply.

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