Validation Engineer – GMP, Quality & Process Improvement

1710 embecta Medical I LLC; Holdrege (NE); On-site; USD 90,000 - 120,000; Full time

Job summary

embecta is seeking a Site Validation Engineer in Holdrege, Nebraska to execute validation initiatives supporting product design, maintain the site validation process, and provide cross-functional Quality Systems/Engineering support.

You will develop and maintain the Validation Master Plan, lead risk assessments and DOE, train teams, approve validation protocols, and contribute to continuous improvement while ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor of Science in Engineering required; 3+ years quality experience including validation.
• Proficiency with statistical methods and quality engineering tools.
• Familiar with 21CFR820 and ISO 13485 compliance.

Responsibilities

• Validate and GMP/Compliance training within the plant.
• Develop and maintain the Validation Master Plan and schedule.
• Lead quality engineering activities including risk assessment and DOE.
• Provide visibility of validation activities through metrics and reports.
• Support change control and continuous improvement initiatives.

Skills

Statistical methods

Quality engineering

Root cause analysis

Six Sigma

MS Excel

MS Word

MS Project

Education

Bachelor of Science in Engineering

Tools

Minitab

Job description

embecta is seeking a Site Validation Engineer in Holdrege, Nebraska to execute validation initiatives supporting product design, maintain the site validation process, and provide cross-functional Quality Systems/Engineering support.

You will develop and maintain the Validation Master Plan, lead risk assessments and DOE, train teams, approve validation protocols, and contribute to continuous improvement while ensuring compliance with 21 CFR 820 and ISO 13485.