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Software Validation Specialist

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 they adhere to established performance criteria. This position requires collaboration with various departments and clients to conduct performance qualification (PQ) validations. The engineer will oversee the validation workflow, manage system enhancements, and guarantee the effective deployment and continuous support 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 liaison in project meetings, 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.
  • Provide validation support for new software releases and updates throughout the software development life cycle (SDLC). Develop and implement validation strategies, test scenarios, and summary reports.
  • Evaluate and endorse change controls and PQ documentation in accordance with standard operating procedures (SOPs). Ensure that test scripts effectively assess functional requirements, demonstrating that the software fulfills business objectives.
  • Execute test scripts accurately to validate software functionality. Manage testing data and resolve PQ-related issues identified during audits.
  • Ensure assignments are completed promptly with a focus on quality outcomes. Remain aware of contractual obligations, 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.
  • Outstanding attention to detail, problem-solving capabilities, and the ability to mentor others.
  • Proficient in Microsoft Office Suite and quick to adapt to new software.
  • Excellent organizational skills with the capacity to manage multiple tasks.
  • Comprehensive understanding of clinical trial operations, SDLC, and Good Clinical Practices (GCPs).
  • Adept at troubleshooting, analyzing software issues, and evaluating test failures.
  • Ability to review and critique SDLC documentation and provide constructive feedback.