Site Validation Engineer

Position : Site Validation Engineer

Location : Holdrege NE 68949

Salary : $85000 annually

H1B / C2C / VISA SPONSORSHIP : NO

Relocation Expenses / Assistance : NO

Job Description :

• Work Style : Onsite (Non-negotiable)
• The salary is around $85k with a 5% bonus.
• Travel Reimbursement for Interviews : Yes, they will assist with travel reimbursement for interviews.
• The Site Validation Engineer is responsible for execution and implementation of validation initiatives in support of product design activities and maintenance of the site validation process.
• Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group as well as active participation in preparation and conduction of FDA, ISO, or other 3rd party audits. This position is also responsible for validation and GMP / Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders.
• This position is responsible for building sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards.
• 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.

Job Requirement :

Preferred Requirements :

Salary : $85,000