Site Validation Engineer - Medical Devices, GMP & Quality

embecta; Holdrege (NE); On-site; USD 85,000 - 120,000; Full time

Job summary

embecta is a global medical device company focused on insulin delivery and diabetes care, expanding to serve more patients and providers. The Site Validation Engineer will execute validation activities in support of product design, maintain validation processes, and collaborate with Quality Engineering and Quality Systems to ensure regulatory compliance.

Responsibilities include leading validation planning, training, change control, and continuous improvement using Lean and Six Sigma

Qualifications

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

Responsibilities

• Execute and implement validation initiatives in support of product design.
• Maintain the site validation process and validate changes.
• Provide quality engineering guidance with RCA, FMEA, DOE, risk assessment and control plans.
• Track validation activities and plant metrics; report progress.
• Assist change management and liaise between core team and Global quality.
• Approve validation protocols and reports per procedures.
• Lead continuous improvement using Lean and Six Sigma tools.
• Support audits and ensure compliance with quality systems and regulatory requirements.

Skills

Statistical analysis

Quality engineering principles

Failure analysis

Verbal & written communication

Project management

Education

Bachelor of Science in Engineering

4-year college degree required

Tools

Minitab

MS Word

MS Excel

MS Project

Job description

embecta is a global medical device company focused on insulin delivery and diabetes care, expanding to serve more patients and providers. The Site Validation Engineer will execute validation activities in support of product design, maintain validation processes, and collaborate with Quality Engineering and Quality Systems to ensure regulatory compliance.

Responsibilities include leading validation planning, training, change control, and continuous improvement using Lean and Six Sigma