Senior Validation and Compliance Engineer
Company: Imperatrix Datum Solutions Corporation
Posted on: February 23, 2021
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
- 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
- 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
- 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
- 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
- Implementation of study imaging analysis platform
- Executing validation projects (as assigned)
- SMO / CRO Site Validation Lead activities including but not
- Equipment calibration/preventative maintenance
- Validation support for core lab and clinical operations;
including metrology, specimen, and drug storage equipment and
- 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
- 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)
- Imaging Core Lab and/or Contract Research Organization
experience is a plus.
- Ability to communicate clearly both verbally and in
- 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
- 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
- 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
Fax 480.314.3080 9977 95th Street, Suite 101
Scottsdale, AZ 85258
Fax 480.314.3080 460 Totten Pond Rd, Ste 420
Waltham, MA 02451-1991
Keywords: Imperatrix Datum Solutions Corporation, Scottsdale , Senior Validation and Compliance Engineer, Engineering , Scottsdale, Arizona
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