IT Validation Engineer

3 weeks ago

Copenhagen, Copenhagen, Denmark Nomeco AS Full time
About the Job

As a Validation Specialist at Nomeco A/S, you will be part of a dynamic team responsible for ensuring the validated state of our facilities and equipment in Nomeco. You will work closely with our logistics team and other departments to ensure the quality and safety of our products.

Key Responsibilities
  • Validate infrastructure, equipment, and IT systems in accordance with Nomeco's procedures, including the development and implementation of VP, URS, risk assessment, IQ/OQ/PQ, and test execution and reporting.
  • Participate in projects as a validation expert, developing URS, etc., in close collaboration with the logistics team and other departments in Nomeco.
  • As an IT validation specialist, you will be an active sparring partner for system owners of IT systems, including root-cause analysis of deviations, change management, and procurement of new systems.
  • Participate in client audits and inspections by regulatory authorities.
  • Collaborate with the QA department on the development and implementation of validation processes.
Requirements
  • You are likely an engineer, quality, or IT graduate, or have experience with the above tasks from a similar job.
  • Experience with validation of infrastructure and equipment for the pharmaceutical industry (GMP/GDP), including development and implementation of this.
  • Practical experience with risk assessments (FMEA), change management (CR), and deviations (NC/VNC).
  • Experience with IT validation in the pharmaceutical industry (GMP/GDP), including development and implementation of this.
  • Familiarity with regulatory requirements for validation, including EU GDP, EU GMP Annex 15, EU GMP Annex 11, and GAMP 5.
  • You have an interest and flair for good testing and documentation practices and are able to quickly understand guidelines and standards.
About You

You have a strong customer focus and always focus on creating value for the company. You are an open and positive team player, have a systematic, structured, and thorough working method with a focus on delivering high quality on time. You are outgoing and service-minded. Your qualifications and competencies in validation and quality assurance make you a good sparring and collaboration partner.

To be successful in the job, you must be proactive and have a desire to work both independently and 'across' in the company and be involved in ensuring other departments' involvement and engagement.

You can expect a positive and informal work environment with competent and experienced colleagues, where you will have a lot of responsibility and a lot of opportunity to define and shape the development in Nomeco.

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