ValGenesis Validation Engineer

3 weeks ago

Canada, CA I.T. Solutions, Inc. Full time

Role: ValGenesis Validation Engineer

Location: NEAR SHORE - Brazil/Puerto Rico/Canada

Length: Long-term rolling contract


Job Description:


The ValGenesis Validation Engineer is responsible for implementing and validating the ValGenesis Validation Lifecycle Management System (VLMS) in regulated environments, primarily within pharmaceutical, biotechnology, and healthcare industries. This role focuses on ensuring ValGenesis meets regulatory, technical, and operational standards through structured validation activities, rigorous testing, and comprehensive documentation. The engineer will work closely with cross-functional teams to ensure the system's compliance with GMP, GCP, and other industry regulations.


Key Responsibilities:


System Validation and Compliance

  • Develop and execute validation protocols (IQ/OQ/PQ) for the ValGenesis system, ensuring alignment with industry standards.
  • Draft validation plans, testing scripts, traceability matrices, and system configuration specifications.
  • Conduct comprehensive testing to verify system functionality, performance, and compliance with regulatory requirements, including 21 CFR Part 11 and Annex 11.


Documentation and Regulatory Adherence

  • Create, review, and maintain detailed validation documentation, including validation plans, risk assessments, and summary reports.
  • Ensure all documentation adheres to regulatory compliance standards (e.g., FDA, EMA) and company SOPs.
  • Maintain up-to-date knowledge of industry standards and best practices in validation, ensuring documentation is audit-ready.


System Implementation and Configuration

  • Collaborate with IT, QA, and cross-functional teams during the installation, configuration, and implementation of the ValGenesis system.
  • Oversee system configuration and customization to align with client-specific requirements and ensure adherence to validation protocols.
  • Conduct system troubleshooting, root cause analysis, and work closely with vendors or IT for issue resolution.


Risk Management and Quality Assurance

  • Perform risk assessments to identify and mitigate potential issues in the validation process, focusing on data integrity and system security.
  • Establish procedures for change control, deviation management, and periodic system reviews to ensure continuous compliance.
  • Conduct internal audits and participate in external audits, providing necessary validation documentation and expertise.


Training and User Support

  • Develop and conduct training sessions for users on system functionalities, validation processes, and compliance standards.
  • Serve as the primary point of contact for ValGenesis-related inquiries, troubleshooting, and ongoing support.
  • Create user manuals, SOPs, and guidelines to support end-users in system navigation and regulatory adherence.


Required Qualifications:

  • Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
  • Experience:
  • Minimum of 2-3 years in system validation, with specific experience in ValGenesis or similar Validation Lifecycle Management Systems.
  • Proven expertise in computer system validation (CSV) within regulated industries (e.g., pharmaceuticals, medical devices).


Skills:

  • In-depth knowledge of regulatory standards (e.g., 21 CFR Part 11, GAMP 5, EU Annex 11).
  • Strong experience with validation documentation, risk assessments, and system testing.
  • Excellent analytical, organizational, and documentation skills.
  • Strong communication skills for cross-departmental collaboration and user training.
  • Preferred Qualifications:
  • Certification in quality management or regulatory compliance (e.g., ASQ, RAPS).
  • Familiarity with GMP, GLP, GCP, and other regulatory frameworks.
  • Experience with other electronic validation management systems or quality management systems (QMS).


The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.


I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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