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CSV Engineer

Date Posted: February 23, 2024

Job Description

We are looking for a meticulous and experienced CSV Engineer to join our team. In this critical role, you will be responsible for ensuring that all computerized systems used within our operations meet the stringent regulatory standards of the pharmaceutical industry. Your expertise in computer system validation will be vital in maintaining the integrity, reliability, and compliance of our IT systems and software applications.

Key Responsibilities

  • Plan, execute, and oversee the validation process for computerized systems, ensuring compliance with industry standards and regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
  • Develop and review validation documentation, including Validation Plans, Requirements Specifications, Test Protocols, and Summary Reports.
  • Work closely with IT, QA, and functional departments to understand system functionalities and to ensure systems are validated for their intended use.
  • Conduct risk assessments for computerized systems to identify and mitigate potential validation and compliance risks.
  • Collaborate with system owners and project teams to resolve any issues identified during the validation process.
  • Ensure that change control procedures are followed for all system changes, and re-validation activities are conducted as necessary.
  • Stay current with the latest industry trends, regulatory guidelines, and best practices in computer system validation.
  • Provide training and support to project teams and end-users on validation protocols and compliance issues.

Required Qualifications and Skills

  • Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
  • A minimum of 3 years’ experience in computer system validation within the pharmaceutical, biotechnology, or related regulated industry.
  • In-depth knowledge of regulatory requirements related to computer system validation, including FDA 21 CFR Part 11 and EU Annex 11.
  • Experience with GAMP 5 guidelines and risk-based approach to computer system validation.
  • Strong analytical and problem-solving skills, with the ability to manage multiple projects and deadlines.
  • Excellent written and verbal communication skills, with proficiency in creating clear and detailed validation documentation.
  • Strong interpersonal skills, with the ability to work effectively both independently and 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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