What are the responsibilities and job description for the Direct Hire : Site Validation Engineer position at Sunrise Systems?
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 :
Preferred Requirements :