Validation Engineer III

4 weeks ago

Reston, Virginia, United States Intellectt Inc Full time

Job Title: Validation Engineer III

Job Summary:

We are seeking a highly skilled Validation Engineer III to join our team at Intellectt Inc. As a key member of our engineering team, you will be responsible for planning, developing, and implementing documentation, procedures, and trainings necessary for the engineering team.

Key Responsibilities:

  • Facilitate Facilities Validation Engineering for Facilities Projects
  • Develop and implement validation plans, user requirement specifications, functional requirement specifications, system design specifications, and traceability matrices
  • Participate in the validation life cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, and validation testing
  • Generate validation protocols, completion reports, and statistical analysis of data to support reports
  • Review and approve validations and completion reports for new and existing computer and automation systems
  • Troubleshoot computer and automation systems that do not perform as intended during validation runs
  • Recommend process and quality improvements as part of validation runs
  • Work with new and existing manufacturing and laboratory equipment, processes, utilities, and facilities with computer or automation systems
  • Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of procedures, actions, and documentation necessary to ensure compliance
  • Analyze the results of testing and determine the acceptability of results against predetermined criteria
  • Evaluate, investigate, and document non-conformances incidents and/or protocol deviations
  • Complete assigned non-conformance and CAPA investigations and prepare investigation reports
  • Manage and supervise the installation of equipment and controls/software modifications for automated equipment
  • Assist with vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, set-up, training, start-up, and troubleshooting
  • Lead process improvement projects to improve the validation of computerized systems
  • Oversee validation contractor resources
  • Generate and report metrics to monitor the performance of validation systems
  • Prepare information for quality management reviews and operational reviews
  • Develop and maintain an effective cross-functional working relationship with plant and corporate manufacturing, engineering, regulatory, and quality assurance personnel
  • Work on project teams with other internal departments, external vendors, and customers as required
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions
  • Participate in external audits

Requirements:

  • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements
  • Knowledge in organizational excellence and lean/six sigma
  • Strong project management skills
  • Ability to lead teams through complex projects and provide departmental technical leadership
  • Thorough understanding of verification and validation processes
  • Strong knowledge and understanding of computer systems validation life cycle and regulatory requirements
  • Excellent communication skills and a strong track record of working cross-functionally
  • Demonstrated ability to think strategically

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