Computer System Validation Engineer Job at Katalyst Healthcares & Life Sciences, Scottsdale, AZ

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  • Katalyst Healthcares & Life Sciences
  • Scottsdale, AZ

Job Description

Job Description

Job Description

Responsibilities:

  • Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations.

  • Develop, review, and approve validation documents, including validation plans, test scripts, and final reports.

  • Coordinate and conduct validation activities in accordance with project timelines and business objectives.

  • Implement and manage document control processes and systems.

  • Evaluate and recommend improvements to existing systems and processes to enhance efficiency and compliance.

  • Provide technical support and training to other team members on computer system validation and related topics.

  • Participate in internal and external audits, ensuring all computer systems are compliant.

  • Oversee ERP implementation, ensuring seamless integration with existing systems.

  • Stay updated with the latest industry trends, regulations, and validation standards.

Requirements:

  • Bachelor's degree in computer science, Engineering, or a related field.

  • A minimum of 5 years of experience in Computer System Validation (CSV) in the engineering industry.

  • Proficient knowledge of Document Control, 21 CFR Part 11, FDA regulations, cGMP regulations, and CSV.

  • Proven experience in ERP implementation.

  • Strong understanding of computer systems, including hardware, software, networking, and security.

  • Excellent problem-solving skills and the ability to handle multiple projects simultaneously.

  • Strong written and verbal communication skills.

  • Ability to work in a team and independently as needed.

  • High attention to detail and accuracy.

  • Proactive, self-motivated, and able to work under minimal supervision.

  • Certification in Computer System Validation or a related field would be an added advantage.

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