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Quality Assurance Validation Engineer

2 months ago

New York, New York, United States Novozen Healthcare LLC Full time

Job Title: Validation Engineer

Overview: The Validation Engineer plays a crucial role in supporting software applications and laboratory equipment, ensuring that their functionality aligns with established standards. This position requires collaboration with various departments and clients to carry out performance qualification (PQ) validations. The engineer will oversee the validation process, manage system enhancements, and guarantee the effective deployment and ongoing maintenance of software solutions.

Additional Information:

  • No C2C (Corp-to-Corp) arrangements are permitted.
  • This position is available in various locations.

Key Responsibilities:

  • Serve as the validation representative in project team discussions, completing designated tasks, contributing insights on upcoming software versions, and managing change requests. Provide regular updates to management regarding project schedules, budgets, and resource limitations.
  • Deliver validation support for new software launches and updates throughout the software development life cycle (SDLC). Develop and implement validation strategies, testing scenarios, and summary reports.
  • Evaluate and endorse change controls and PQ documentation in accordance with standard operating procedures (SOPs). Ensure that testing scripts adequately challenge functional requirements, demonstrating that the software fulfills business objectives.
  • Precisely execute testing scripts to validate software functionality. Manage testing data and resolve PQ-related issues arising from audits.
  • Ensure timely completion of tasks with a focus on quality outcomes. Remain aware of contractual commitments, client expectations, and applicable regulations.
  • Engage in identifying user needs and system architecture, assisting in the creation and review of system documentation such as requirements and design specifications.

Qualifications:

  • Education: Bachelor’s degree or equivalent in a relevant discipline.
  • Experience: At least 2 years of relevant experience, or a combination of education, training, and experience.
  • Skills:
  • Client-oriented with strong interpersonal, verbal, and written communication abilities.
  • Exceptional attention to detail, problem-solving capabilities, and the ability to instruct others.
  • Proficient in Microsoft Office Suite and quick to learn new software applications.
  • Strong organizational skills with the capacity to manage multiple tasks effectively.
  • Solid understanding of clinical trial operations, SDLC, and Good Clinical Practices (GCPs).
  • Adept at troubleshooting, analyzing software issues, and evaluating test failures.
  • Capable of reviewing and critiquing SDLC documentation and providing constructive feedback.