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Direct Hire : Site Validation Engineer

Sunrise Systems
Holdrege, NE Full Time
POSTED ON 4/25/2025
AVAILABLE BEFORE 5/18/2025

Job Title : Site Validation Engineer

Duration : Direct Hire / Full Time

Location : Holdrege, NE

Onsite position

Job Description :

Site Validation Engineer

Essential functions include but are not limited to :

  • Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
  • Develop and maintain the Validation Master Plan and validation tracking schedule.
  • Provide visibility related to all validation activities through tracking and reporting plant metrics.
  • Support and influence change management within the plant : liaison between the core team, program managers, and Global quality.
  • Conduct training relevant to validation process and procedures.
  • Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
  • Participate in Global validation team meetings as required.
  • Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
  • Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
  • Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
  • Build interactive working and strategic relationships between company Holdrege manufacturing, business and corporate quality management and other staff.
  • Perform other duties as assigned by the Team Leader and required to support the needs of the business.

Basic Requirements :

  • B.S. degree in Engineering (Industrial, Mechanic) or similar
  • 3 Years of Quality experience including Validation and Quality Engineering responsibilities.
  • Statistical and problem-solving skills
  • Strong understanding of failure analysis
  • Experience with Statistical software
  • Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
  • Preferred Requirements :

  • Demonstrate success with statistical and problem-solving methodologies.
  • Strong understanding of failure analysis, test methods and engineering tolerances.
  • Strong verbal, written and interpersonal skills.
  • Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
  • Six Sigma Certification
  • ASQ CQE
  • Working knowledge of 21CFR820
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