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CSV Automation Engineer

Date Posted: February 23, 2024

Job Description

We are looking for a skilled CSV Automation Engineer to join our team. This role involves ensuring the reliability, consistency, and compliance of automated systems used within our operations. The successful candidate will be responsible for the validation of computerized systems to ensure they meet all regulatory standards and industry best practices, with a particular focus on automation technologies. Your expertise in automating validation processes will be critical in enhancing efficiency and ensuring the integrity of our computerized systems.

Key Responsibilities

  • Develop and implement strategies for the automation of computer system validation processes to enhance efficiency and compliance.
  • Design, execute, and document validation tests for automated systems, ensuring they meet regulatory requirements and industry standards.
  • Collaborate with IT and engineering teams to integrate automation solutions within the computer system validation framework.
  • Maintain up-to-date knowledge of regulatory guidelines related to CSV, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Analyze and interpret data from automated validation tests, identifying areas for improvement and ensuring continuous compliance.
  • Develop and maintain comprehensive documentation for automated validation activities, including plans, protocols, test cases, and reports.
  • Provide technical guidance and support to teams in the selection and use of automation tools and technologies for system validation.
  • Lead initiatives to identify and implement new technologies and methodologies to improve the validation process and compliance posture.

Required Qualifications and Skills

  • Bachelor’s degree in Computer Science, Engineering, or a related field, with a strong emphasis on automation technologies.
  • Minimum of 3 years of experience in CSV, with a specific focus on automation within the pharmaceutical, biotechnology, or related regulated industry.
  • Strong understanding of regulatory requirements and industry standards for computer system validation, including GAMP 5 guidelines.
  • Experience with automation tools and technologies relevant to CSV processes.
  • Proficient in programming and scripting languages commonly used in automation.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong documentation and communication skills, with the ability to convey complex information clearly and concisely.
  • Proactive, with a continuous improvement mindset and the ability to work independently as well as part of a team.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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