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Senior Validation and Compliance Engineer

Company: Imperatrix Datum Solutions Corporation
Location: Scottsdale
Posted on: February 23, 2021

Job Description:

Home -- Jobs -- Senior Validation and Compliance Engineer Senior Validation and Compliance Engineer Imaging Endpoints (IE) is an Imaging Research and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts and are an affiliate of HonorHealth, one of the largest healthcare systems nationally. Additionally, IE is also an affiliate of Scottsdale Medical Imaging Limited (SMIL/SDI), one of the largest private radiology groups in the U.S. We operate in over thirty countries globally and are recognized as the preeminent iCRO for complex trials, particularly within oncology. JOB DESCRIPTION The primary responsibility of the Sr. Validation and Compliance Engineer role is to assist the Director of Compliance and Regulatory Affairs, in the development, coordination, and execution of the day-to-day tasks associated with validation and compliance engineering projects for Imaging Endpoints. The Sr. Validation and Compliance Engineer is a compliance and regulatory affairs solutions focused individual; that acts as the lead facilitator for validation projects conducted by contractors and/or other internal support teams; designs strategies and implements compliance through validation, documentation, risk assessment and mitigation for new and/or existing systems; the lead validation resource for site-level laboratory equipment and/or system implementations. This position is a lead technical resource on project teams to ensure that the overall validation packages meet and/or exceed all applicable industry standards and regulatory guidelines. The Sr. Validation and Compliance Engineer is key in achieving business and stakeholder needs with respect to clinical research quality assurance principles and practices. ESSENTIAL JOB FUNCTIONS

  • Assist in establishing, implementing, and maintaining validation procedures and controls using lean principles.
  • Lead company-wide gap analysis for specific regulatory changes and support efforts to update processes and documentation accordingly.
  • Develop standard templates for validation including documentation templates (UAT, IQ, OQ, PQ), flow charts, checklists, standard operating procedures, work instructions, etc.
  • Create validation master plans, process flow diagrams, test cases that incorporate equipment and software features and future enhancements.
  • Design validation study strategies (e.g., sampling plan development, testing, or analytical methodologies).
  • Develop and execute validation protocols and necessary documentation to complete validations.
  • Review statistical analysis in order to detect and control variability (as requested).
  • Conduct Risk Analysis and document a risk-based approach to the validation life cycle.
  • Conduct investigations of validation deviations in a timely manner and document findings.
  • Compose reports for equipment and software validation projects for UATs, IQs, OQs, and PQs
  • Management of testing equipment, their suppliers and calibration resources.
  • Perform continuous improvement and/or preventative maintenance evaluations of equipment and/or processes.
  • Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional, and organizational relationships to drive quality system requirements.
  • Assist Compliance and Regulatory Affairs management during Internal Audits, Sponsor Audits, or Regulatory Inspections as an on-site validations representative.
  • Perform other duties as assigned by Compliance and Regulatory Affairs management. Validation and Technical Services
    • Configuration Management and Change Control (CMCC) activities including, but not limited to
    • Guidance and coordination for incoming and existing systems and processes
    • Implementation of study imaging analysis platform
    • Executing validation projects (as assigned)
    • SMO / CRO Site Validation Lead activities including but not limited to
    • Equipment calibration/preventative maintenance coordination
    • Validation support for core lab and clinical operations; including metrology, specimen, and drug storage equipment and monitoring
    • System implementation (laboratory equipment, software tools, etc.) Quality Management System
      • Ensure appropriate validation systems and processes (e.g., SOPs) are developed and maintained to meet industry standards
      • Implement lean six-sigma tools as part of the overall QMS strategy
      • Internal and external auditing support EDUCATION AND EXPERIENCE
        • Bachelor's degree in Engineering, Computer Science, or other related scientific discipline.
        • Certified Quality Engineer and/or Six Sigma Green Belt Certification or Higher (preferred)
        • Minimum five (5) years of experience in a regulated GxP industry with at least three (3) years of validation experience in pharmaceuticals and/or medical device.
        • Knowledge and understanding of
        • 21CFR Part 211
        • 21CFR Part 312
        • ISO 13485
        • Good Clinical Practices (ICH E6 GCP)
        • Good Manufacturing Practices (GMPs)
        • Working knowledge of GAMP 5 Risk Based and Compliance Validation Practices and Software Development Life Cycle (SDLC) management
        • Imaging Core Lab and/or Contract Research Organization experience is a plus.
        • Ability to communicate clearly both verbally and in writing.
        • Proficiency in MS Office and internet applications.
        • Technical lead experience in validation and compliant operation of complex clinical data software and hardware systems.
        • Operational familiarity with imaging software and administrative functions, DICOM networking, and PACS. SKILLS
          • Work precisely and in compliance with all procedures, rules and regulations.
          • Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
          • Excellent interpersonal, organizational, and communication skills, including oral and written.
          • Self-motivated and able to grasp new concepts and learn quickly as well as motivate others.
          • Ability to manage projects and deliverables with a high level of accuracy and completeness.
          • Ability to work independently with little supervision.
          • Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel and Power Point. PHYSICAL REQUIREMENTS
            • While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear.
            • The employee is frequently required to sit.
            • Specific vision abilities required by this job include close vision, color vision, ability to adjust focus. Imaging Endpoints is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. 9977 N. 90th Street, Suite 300
              Scottsdale, AZ 85258
              Phone 480.314.3070
              Fax 480.314.3080 9977 95th Street, Suite 101
              Scottsdale, AZ 85258
              Phone 480.314.3070
              Fax 480.314.3080 460 Totten Pond Rd, Ste 420
              Waltham, MA 02451-1991
              Phone 480.314.3070
              Fax 480.314.3080

Keywords: Imperatrix Datum Solutions Corporation, Scottsdale , Senior Validation and Compliance Engineer, Engineering , Scottsdale, Arizona

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