CSV Engineer (Computerized System Validation)

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Sector

CSV Engineer (Computerized System Validation)

Location

Copenaghen

Level

CSV Engineer (Computerized System Validation)

Job description

Job Summary


As a CSV Engineer, you will be responsible for the Computerized Systems Validation (CSV) scope and collaboration with the Automation team. Your expertise in CSV, along with experience in large-scale projects and PLC/DeltaV systems, will contribute to the successful execution of projects in biopharmaceutical manufacturing facilities


Responsibilities

  • Lead the Computerized Systems Validation (CSV) process to ensure compliance with industry regulations and standards.
  • Collaborate with the Automation team to integrate CSV activities within project timelines.
  • Develop and execute validation protocols, test documentation, and CSV project deliverables.
  • Liaise with departments, project managers, and vendors to coordinate CSV activities.
  • Provide technical support to the Automation group during field execution and report writing.
  • Generate and manage project change controls as required.
  • Support Design Qualification efforts and participate in risk assessments.
  • Adapt to changing project requirements and timelines.
  • Maintain accurate documentation and records related to CSV activities.


Profile wanted

  • Bachelor's degree in a relevant field (Engineering, Computer Science, etc.) is preferred.
  • Minimum of 4/5 years of experience in CSV.
  • Strong knowledge and experience with PLC and DeltaV systems.
  • Experience working on large-scale projects.
  • Preferred familiarity with design and construction projects in biopharmaceutical manufacturing facilities.
  • Excellent communication and interpersonal skills.
  • Strong problem-solving and analytical abilities.
  • Ability to work effectively in a team environment.


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