Validation Engineer

EXPERIENCE & EDUCATION

• Four-year college Bachelor of Science degree required. Bachelor of Science degree in Engineering desired.

• 3+ Years Quality experience including Validation and Quality Engineering responsibilities.

1. 1Responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders.

1. 2Develop and maintain the Validation Master Plan and validation tracking schedule.

1. 3Provide critical quality engineering direction with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.

1. 4Provide visibility related to all validation activities through tracking and reporting plant metrics.

1. 5Support and influence change management within the plant: liaison between the core team, program managers, and Global quality.

1. 6Conduct training relevant to validation process and procedures.

1. 7Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.

1. 8Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.

1. 9Lead and support quality engineering activities associated with change control, continuous improvement, and process optimization initiatives by ensuring appropriate risk assessments, validation requirements, product and process impact assessments, and effectiveness monitoring are completed in accordance with established quality system procedures.

1. 10Identify, prioritize, and support continuous improvement opportunities by analyzing quality, manufacturing, and customer feedback data to drive sustainable process and product improvements.

1. 11Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.

1. 12Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles. Make basic procedural updates.

1. 13Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.

1. 14Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.