Validation Engineer – Medical Devices & CQV Specialist

S & V Tek Systems; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

S & V Tek Systems LLC is a leading provider of business and technology services, focused on advancing clients’ transformation initiatives. The role covers leading process validations for single-use medical devices, developing validation protocols, and supporting audit readiness and remediation efforts.

You will apply Lean Six Sigma techniques to optimize validation workflows, support CQV activities for warehouse spaces, and contribute to regulatory review-ready documentation.

Qualifications

• Lead and execute Process Validations and Test Method Validations for single use medical devices.
• Develop validation protocols, define critical parameters, execute validation studies, analyze results, and author final validation reports
• Support validation activities including documentation updates, change control and remediation-led updates
• Apply Lean and Six Sigma techniques including process flow mapping, VSM, time-motion studies to refine warehousing and validation processes

Responsibilities

• Lead and execute Process Validations and Test Method Validations for single use medical devices.
• Develop validation protocols, define critical parameters, execute validation studies, analyze results, and author final validation reports
• Support validation activities including documentation updates, change controls, and remediation-driven updates
• Support manufacturing lines during audits and actively participate in audit remediation efforts
• Conduct root cause analysis when validations fail and define corrective actions
• Participate in installation, testing, and validation of automation technologies deployed to support material movement and distribution

Skills

Process validations

Test method validations

Root cause analysis

Lean Six Sigma

Validation reports

Tools

IQ/OQ/PQ protocols

ASRS

AGV

AMR technologies

Job description

S & V Tek Systems LLC is a leading provider of business and technology services, focused on advancing clients’ transformation initiatives. The role covers leading process validations for single-use medical devices, developing validation protocols, and supporting audit readiness and remediation efforts.

You will apply Lean Six Sigma techniques to optimize validation workflows, support CQV activities for warehouse spaces, and contribute to regulatory review-ready documentation.