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CSV Engineer

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Jersey City, New Jersey, United States EPM Scientific Full time

We are seeking a highly skilled Computer System Validation (CSV) Engineer to join our client on a contract basis. This role is crucial for ensuring the validation and compliance of computerized systems in a regulated, GxP-compliant environment, contributing to the production of innovative oncology treatments.

Key Responsibilities:

  • Lead and Execute CSV Activities: Oversee and perform all aspects of CSV to ensure computerized systems meet operational requirements and comply with GxP regulations.
  • Validation Documentation: Author and execute comprehensive validation documents, including Validation Plans, Test Plans, Test Scripts, and Validation Summary Reports.
  • System Risk Assessments: Perform risk assessments to evaluate GxP applicability, determine validation scope, and identify potential risks.
  • Discrepancy and Deviation Management: Manage and track discrepancies and deviations during test execution, ensuring timely and compliant resolution.
  • Change Control Support: Provide validation support for system changes, including impact assessments and documentation of change qualifications.
  • Ongoing Compliance: Assist in periodic reviews of validated systems to ensure continued compliance with regulatory standards.
  • Validation System Administration: Administer electronic validation lifecycle management systems (e.g., ValGenesis), ensuring efficient use and compliance.
  • End User Training and Support: Train and support end users on validation systems, ensuring effective and compliant use.
Key Qualifications:
  • Experience: Proven experience in CSV within the pharmaceutical or life sciences industry, preferably with a focus on oncology treatments.
  • Regulatory Knowledge: Strong understanding of GxP regulations (e.g., GMP, GCP) and the ability to apply risk-based validation methodologies.
  • Documentation Expertise: Demonstrated expertise in developing and executing validation documentation.
  • System Lifecycle Management: Hands-on experience with computerized systems lifecycle management in GxP-regulated environments.
  • ValGenesis Proficiency: Proficiency with validation management systems, such as ValGenesis or similar platforms.
  • Analytical Skills: Excellent problem-solving and analytical skills, with attention to detail.
  • Communication and Collaboration: Strong communication skills with the ability to collaborate effectively across multidisciplinary teams.
  • Technical Skills: Strong understanding of computer systems, databases, and software applications used in pharmaceutical manufacturing and clinical operations.